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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06065345
Registration number
NCT06065345
Ethics application status
Date submitted
18/09/2023
Date registered
3/10/2023
Date last updated
22/05/2024
Titles & IDs
Public title
BRight Pharmacokinetic Study
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Scientific title
BIOTRONIK- Pharmacokinetic Study of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Superficial Femoral and Proximal Popliteal Artery
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Secondary ID [1]
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C2304
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - BRight DCB
Experimental: BRight DCB - Single arm study. All subjects will be treated with the BRight DCB
Treatment: Devices: BRight DCB
The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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AUC 0-t
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Assessment method [1]
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Area under the drug concentration-time curve, calculated using linear trapezoidal summation from time zero to time tlast, where tlast is the time of the last measurable concentration (Ct).
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Timepoint [1]
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0 to 24 hours
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Primary outcome [2]
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AUC 0-inf
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Assessment method [2]
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Area under the drug concentration-time curve from time zero to infinity
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Timepoint [2]
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0 to 24 hours
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Primary outcome [3]
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Cmax
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Assessment method [3]
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Maximum observed drug concentration
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Timepoint [3]
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0 to 24 hours
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Primary outcome [4]
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Terminal Elimination Rate Constant (?z)
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Assessment method [4]
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Apparent terminal elimination rate constant, calculated by linear regression of the terminal linear portion of the log concentration vs. time curve
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Timepoint [4]
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0 to 24 hours
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Primary outcome [5]
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Terminal Elimination Half-life (t1/2)
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Assessment method [5]
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Apparent terminal elimination half-life, calculated as ln(2)/?z
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Timepoint [5]
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0 to 24 hours
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Primary outcome [6]
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tmax
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Assessment method [6]
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Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
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Timepoint [6]
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0 to 24 hours
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Primary outcome [7]
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Drug clearance (CL)
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Assessment method [7]
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Apparent total clearance, calculated as dose/AUC0-inf
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Timepoint [7]
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0 to 24 hours
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Primary outcome [8]
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Apparent volume of distribution at the terminal phase (Vz)
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Assessment method [8]
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Apparent volume of distribution at the terminal phase, calculated as CL/?z
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Timepoint [8]
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0 to 24 hours
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Primary outcome [9]
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Metabolic Ratio (MR)
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Assessment method [9]
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Metabolic ratio calculated as the molar concentration of sirolimus AUC0-inf to BIOtorcin AUC0-inf
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Timepoint [9]
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0 to 24 hours
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Secondary outcome [1]
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Device success
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Assessment method [1]
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Successful delivery, balloon inflation/deflation and retrieval of the intact trial device
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Timepoint [1]
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during procedure
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Secondary outcome [2]
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Acute technical success
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Assessment method [2]
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Successful vascular access and completion of the endovascular procedure and immediate achievement of a final residual diameter stenosis of =30% of the treated lesion by core laboratory assessed QVA on the completion angiography with no bailout stenting
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Timepoint [2]
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during procedure
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Secondary outcome [3]
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Acute procedural success
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Assessment method [3]
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Technical success without the occurrence of death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR within 72 hours of the index procedure
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Timepoint [3]
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72 hours post procedure
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Secondary outcome [4]
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Major adverse event (MAE) rate
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Assessment method [4]
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MAE is a composite of device or procedure related death within 30 days post index procedure, or major index limb amputation, or cd TLR at 1, 6 and 12 months post index procedure
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Timepoint [4]
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1, 6 and 12 months post index procedure
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Secondary outcome [5]
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Clinically-driven Target Lesion Revascularization (cd TLR) rate
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Assessment method [5]
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cd TLR is defined as any repeat intervention of the target lesions or surgical bypass of the target vessel performed for restenosis > 50% or other complication involving the target lesion, after documentation of recurrent clinical symptoms of the patient.
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Timepoint [5]
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1, 6 and 12 months post index procedure
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Secondary outcome [6]
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Clinically-driven Target Vessel Revascularization (cd TVR) rate
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Assessment method [6]
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cd TVR, defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel, after documentation of recurrent clinical symptoms of the patient.
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Timepoint [6]
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1, 6 and 12 months post index procedure
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Secondary outcome [7]
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All-cause of death rate
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Assessment method [7]
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0
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Timepoint [7]
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1, 6 and 12 months post index procedure
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Secondary outcome [8]
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Target limb major (above the ankle) and minor (below the ankle) amputation rate
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Assessment method [8]
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Timepoint [8]
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1, 6 and 12 months post index procedure
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Secondary outcome [9]
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Change in Rutherford Classification as compared to baseline
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Assessment method [9]
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Timepoint [9]
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1, 6 and 12 months post index procedure
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Secondary outcome [10]
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Change in Ankle Brachial Index (ABI) as compared to baseline
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Assessment method [10]
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Timepoint [10]
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1, 6 and 12 months post index procedure
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Secondary outcome [11]
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Change in Walking Impairment Questionnaire (WIQ) as compared to baseline
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Assessment method [11]
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Timepoint [11]
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1, 6 and 12 months post index procedure
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Secondary outcome [12]
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Target lesion Binary Restenosis rate
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Assessment method [12]
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Defined as duplex ultrasound peak systolic velocity ratio (PSVR) > 2.5 or angiographic assessment which suggests stenosis > 50% by QVA
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Timepoint [12]
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1, 6 and 12 months post index procedure
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Secondary outcome [13]
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Target lesion Primary Patency rate
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Assessment method [13]
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Defined as duplex ultrasound peak systolic velocity ratio (PSVR) = 2.5 or angiographic assessment which suggests stenosis = 50% by QVA and the absence of Clinically-driven TLR (adjudicated by a CEC)
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Timepoint [13]
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1, 6 and 12 months post index procedure
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Secondary outcome [14]
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embolic event of the index limb rate
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Assessment method [14]
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Timepoint [14]
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during procedure
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Eligibility
Key inclusion criteria
1. The subject has provided written informed consent
2. The subject is willing to participate in the clinical investigation and to comply with
the study procedures and follow-up visits
3. Lifestyle-limiting claudication or rest pain requiring treatment of superficial
femoral (SFA) and/or proximal popliteal artery (PPA)
4. Age = 18 years old
5. Rutherford-Becker Clinical Category of 2, 3 or 4
6. Target vessel reference diameter =5 mm and = 6 mm (by visual estimation)
7. De novo lesion with >50% stenosis by operator visual estimate within the SFA and/or
proximal popliteal arteries in a single limb.
8. Lesion must be located = 1 cm below the Common Femoral Artery (CFA) bifurcation and
terminate distally at = 3 cm proximal to the knee joint (radiographic joint space).
9. Single lesion length =170 mm for de novo stenotic lesions, or = 100 mm for occluded
lesions (one long lesion or multiple serial lesions) by operator visual estimate.
Notes: (1) Only 1 lesion per patient can be treated. Multiple serial lesions are
allowed if they can be treated as a single lesion with a maximum of 2 balloons. (2) a
non-occlusive lesion that includes a totally occluded segment along its length are
eligible provided that the overall treated lesion length is =170 mm (with / or without
an occluded segment not greater than 100 mm in length).
10. Successful guidewire crossing of lesion.
11. After pre-dilatation, the target lesion is = 30% residual stenosis with no flow
limiting dissection and treatable with a maximum of 2 balloons.
12. Inflow artery is patent, free from significant lesion stenosis (>50% stenosis
considered significant) as confirmed by angiography.
Note: Where required, inflow iliac arteries (common and external iliac arteries only)
must be successfully treated during the index procedure. Completion angiography must
confirm successful treatment of inflow disease (=50% residual stenosis, no distal
embolization, and no Grade C or greater dissection) prior to pre-dilatation of the
target lesion. Drug-eluting devices are not allowed for treatment of the occluded
inflow iliac arteries.
13. Patency of the popliteal segments P2 and P3 with at least 1 patent infrapopliteal
run-off vessel (that may have a stenosis of less than 50% not interfering with the
outflow to the pedal arch) to the ankle in continuity with the native femoropopliteal
artery, in the target limb confirmed at baseline. (Note: treatment of outflow disease
is permitted. Drug-eluting devices are not allowed for outflow treatment)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Females who are pregnant, lactating, or intended to become pregnant, or males
intending to father children during the study
2. Subject under current medication known to affect CYP3A4 metabolism, or consuming food
or beverages that are known substrates of CYP3A4
3. Contraindication to dual anti-platelet therapy
4. Subject receiving chronic anticoagulation therapy (e.g. low molecular weight heparin,
warfarin, or novel direct oral anticoagulants (N(D)OACs)) if the treatment cannot be
interrupted 48 hours prior to the procedure
5. Known intolerance to study medications, Limus- like drug or contrast agents that in
the opinion of the investigator could not be adequately pretreated
6. Current participation in an investigational drug or another device study
7. History of hemorrhagic stroke within 3 months
8. Patients with a history of Myocardial Infarction (MI) or thrombolysis within 30 days
prior-index procedure
9. Previous or planned surgical or interventional procedure within 14 days before or 30
days after index procedure (successful treatment of the ipsilateral and contralateral
iliac arteries is permitted during the index procedure. Drug-eluting devices are not
allowed for treatment of the occluded inflow iliac arteries)
10. Prior endovascular treatment of the target lesion (e.g., POBA, DCB, BMS, DES, cutting
balloons, scoring balloons, cryoplasty, thrombectomy, atherectomy, brachytherapy or
laser devices)
11. Previous placement of a bypass graft proximal to the target lesion
12. Chronic renal insufficiency (eGFR < 30 mL/min within 72 hours prior to index
procedure)
13. Patient requiring renal replacement therapy
14. No normal proximal arterial segment in which duplex ultrasound velocity ratios could
be measured.
15. Subject is unable to walk without assistance (e.g. walker, cane).
16. Subject is receiving immunosuppressant therapy.
17. Subject has known or suspected active infection at the time of the index procedure.
18. Subject has platelet count < 100,000/mm3 or > 700,000/mm3.
19. Subject has white blood cell (WBC) count < 3,000/mm3.
20. Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.
21. Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the index procedure.
22. Life expectancy less than 12 months due to other comorbidities, that in the
investigators opinion, could limit subject ability to comply with the study required
follow-up visits/procedure and threaten the study scientific integrity
23. Treatment of the contralateral limb during the same procedure or within 30 days
following the study procedure (exclusive of the iliac arteries, which can be treated
during the index procedure if no drug eluting technology is used)
24. Non femoral vascular access
25. Target lesion would require treatment with more than two BRight balloons
26. Known inadequate distal outflow
27. Acute or sub-acute thrombus in the target vessel
28. Aneurysmal target vessel
29. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting
balloon, brachytherapy) during the study procedure in the target lesion or target
vessel
30. Presence of concentric calcification that precludes PTA pre-dilatation
31. Significant contralateral or ipsilateral common femoral disease that requires
intervention during the index procedure
32. Persistent hemodynamically-significant stenosis following predilatation or residual
stenosis of >30%, stent placement, or flow-limiting (Grade D or greater) dissection
following pre-dilatation
33. In-stent restenosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WAU
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik CRC Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized
study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon
at different time points after the balloon deployment.
The study will enroll a maximum of 10 patients at a single site in Australia
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06065345
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Helene KUISSU
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Address
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Country
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Phone
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+41(0)798082147
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06065345
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