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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/NCT03807531




Registration number
NCT03807531
Ethics application status
Date submitted
11/01/2019
Date registered
17/01/2019
Date last updated
18/11/2023

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
N/A
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
Not Applicable
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
The purpose of this study is to evaluate the performance and safety of the Temporary Spur
Stent System (TSS). The TSS is intended for use in conjunction with a commercially available
drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic
lesions.

This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New
Zealand, Germany, and Switzerland.

At least two and no more than 10 sites are expected to participate, with 100 subjects
enrolled (no more than 40 at a single site).

The study follow up will take place over a period of 365 days. A vessel recoil substudy will
be included for a select group of subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03807531
Trial related presentations / publications
Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03807531