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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03807531




Registration number
NCT03807531
Ethics application status
Date submitted
11/01/2019
Date registered
17/01/2019

Titles & IDs
Public title
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
Scientific title
A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States
Secondary ID [1] 0 0
CP-002
Universal Trial Number (UTN)
Trial acronym
DEEPER OUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Temporary Spur Stent System

Other: Treatment with TSS - This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)


Treatment: Devices: Temporary Spur Stent System
Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Freedom from device and procedure-related death through 30 days post-procedure
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Freedom from clinically driven target lesion revascularization through 6 months post procedure.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Decrease in Rutherford class score at 3, 6 and 12 months.
Timepoint [2] 0 0
3, 6, and 12 months
Secondary outcome [3] 0 0
Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
Timepoint [3] 0 0
6 and 12 months

Eligibility
Key inclusion criteria
1. Subject is willing and able to provide informed consent and able to comply with the study protocol.
2. Life expectancy >1 year in the investigator's opinion
3. Subject is > 18 years of age.
4. Subject is Rutherford class 3-5.
5. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
6. Target lesion must meet lesion-specific criteria in pre-screening by angiography (pre-screening with CTA, MRA or selective angiography may be performed prior to the index procedure)
7. Target vessel(s) reconstitutes(s) at or above the medial malleolus, with the target treated segment extending no more than 10 mm beyond the medial malleolus.

Note: If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.

If the peroneal artery is treated, there must be at least one collateral supplying the foot.
8. Target lesion must begin no higher than the tibioperoneal trifurcation (popliteal arteries excluded).
9. Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in diameter, assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:

1. Intravascular Ultrasound (IVUS)
2. Optical Coherence Tomography (OCT)
3. Quantitative Vascular Angiography (QVA).
10. Lesion length must be > 30 mm and < 150 mm.
11. Only one limb may be enrolled per subject. Up to two vessels may be treated per subject; if required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Any treatment of the non-index vessel must be performed prior to the use of the investigative device and only one artery may be treated with the investigative device
12. The total treated segment is defined as the total length of artery treated with the investigational device. Target treatment length is <240 mm with a maximum segment of 150 mm separated by 30 mm of healthy tissue between treated lesions.
13. Successful pre-dilatation of the target lesion as outlined in the procedure instructions, defined as resulting in stenosis <50%, without resulting flow limiting dissection (Type D or greater), thrombus, or aneurysm by angiography prior to the insertion of the investigative device.
14. Iliac, SFA and popliteal inflow lesions can be treated using standard angioplasty and/or an approved stent (no atherectomy) during the index procedure or >30 days prior. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. If pre-screening with angiography, CTA, MRA, or ultrasound has been performed <365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the infrainguinal inflow must still be imaged using angiography during the index procedure. Inflow lesions must have a healthy vessel segment of >30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
15. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing, however, the Temporary Spur Stent System must be deployed from antegrade access
16. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed >30 days prior to the index procedure or > 14 days following the index procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study in the opinion of the investigator.
2. Subject is pregnant or planning to become pregnant during the course of the trial.
3. Subject has an active infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
4. Subject has osteomyelitis or a heel wound.
5. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal or digit amputation) is permitted
6. Recent myocardial infarction or stroke < 90 days prior to the index procedure.
7. Heart failure with Ejection Fraction < 35%
8. Impaired renal function (eGFR <25 mL/min) within 30 days of procedure and subjects on dialysis
9. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
10. Subject receiving chronic or intravenous corticosteroid therapy.
11. Inability to tolerate dual antiplatelet and oral anticoagulation therapy.
12. Known allergies or sensitivities to heparin, antiplatelet, or other anticoagulant therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
13. The subject is currently enrolled in another investigational device or drug trial that may interfere with the endpoints of this study.
14. Known allergy to nitinol or nickel.
15. Prior stent(s) within the target vessel, or bypass surgery of or within the target vessel(s)
16. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments.
17. Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure. Prior bypass above the level of the infrapopliteal arteries is permitted.
18. Previous treatment of inflow lesions, if not treated during the index procedure, must have been performed >30 days prior to the index procedure.
19. Previous treatment of the target vessel <30 days prior to index procedure
20. Angiographic evidence of thrombus within target limb.
21. Inability to obtain antegrade access in the limb from which the investigative device can be deployed.
22. Extremely severe calcification classified as grade 4 as measured by the Peripheral Academic Research Consortium (PARC) score or the Peripheral Arterial Calcium Scoring System (PACSS) that, in the investigator's opinion, would not be amenable to PTA.
23. Type D dissections or greater incurred during pre-dilation or CTO crossing.
24. Significant (>50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Arnsberg
Country [2] 0 0
Germany
State/province [2] 0 0
Bad Krozingen
Country [3] 0 0
Germany
State/province [3] 0 0
Leipzig
Country [4] 0 0
Germany
State/province [4] 0 0
Rosenheim
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Switzerland
State/province [6] 0 0
Lugano

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ReFlow Medical, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ClinLogix. LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MBChB
Address 0 0
Auckland Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03807531