CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
Study Details
Study Description
Brief Summary
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Everolimus-coated balloon Treatment of occlusion or stenosis in Superficial Femoral Artery and Proximal Popliteal Artery with drug-coated balloon |
Device: Peripheral PTA with a drug coated balloon
Peripheral artery angioplasty
|
Outcome Measures
Primary Outcome Measures
- Freedom of Major Adverse Event (MAE) rate [6 months post-procedure]
Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
- Patency [6 months post procedure]
Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).
Secondary Outcome Measures
- Rate of MAE [One year post-procedure]
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
- Patency [12 months post procedure]
Freedom from clinically driven TLR and duplex ultrasonography detected restenosis (ultrasound peak systolic velocity ratio ≤ 2.4 or stenosis ≤50%)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be at least 18 years of age.
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Subject provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
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Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.
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Subjects with symptomatic leg ischemia who do not respond favorably to Exercise Therapy or with symptoms that impact significantly daily life, requiring treatment of SFA or popliteal (P1 segment) artery.
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De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area.
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Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.
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Successful wire crossing of lesion.
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Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).
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Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.
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At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.
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Life expectancy >1 year
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Rutherford classification of 2, 3 or 4.
Exclusion Criteria:
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Pregnant or lactating females.
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Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
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Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
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Known intolerance to study medications, everolimus or contrast agents.
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Doubts in the willingness or capability of the subject to allow follow-up examinations.
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Subject is actively participating in another investigational device or drug study.
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History of hemorrhagic stroke within 3 months of procedure.
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Previous or planned surgical or interventional procedure within 30 days of index procedure.
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Prior vascular surgery of the target lesion.
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Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
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Known inadequate distal outflow.
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Significant inflow disease.
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Acute or sub-acute thrombus in target vessel.
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Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).
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Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
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Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
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Rutherford classification of 0, 1, 5 or 6
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Presence of prohibitive calcification that precludes adequate PTA treatment.
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Subjects held in custody in an institution by official or court order.
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Subject is not covered by any medical insurance coverage.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Polyclinique Les Fleurs | Ollioules | France | 83190 | |
| 2 | Hôpital Paris Saint Joseph | Paris | France | 75014 | |
| 3 | Hôpital Nord Laennec - CHU de Nantes | Saint-Herblain | France | 44800 | |
| 4 | Clinique Pasteur | Toulouse | France | 31300 | |
| 5 | Vivantes Klinikum Neukölln | Berlin | Germany | 12351 | |
| 6 | Jüdisches Krankenhaus Berlin | Berlin | Germany | 13347 | |
| 7 | DIAKO Krankenhaus Flensburg | Flensburg | Germany | 24939 | |
| 8 | Romed Klinikum Rosenheim | Rosenheim | Germany | 83022 |
Sponsors and Collaborators
- Chansu Vascular Technologies
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TP1109