CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

NCT ID: NCT05734157

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2025-08-27

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.

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.

Conditions

Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus-coated balloon

Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.

Group Type: EXPERIMENTAL

Peripheral PTA with a drug coated balloon

Intervention Type: DEVICE

Peripheral artery angioplasty

Interventions

Peripheral PTA with a drug coated balloon

Peripheral artery angioplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.

3. Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.

4. Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.

5. 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.

6. Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.

7. Successful wire crossing of lesion.

8. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).

9. Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.

10. At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.

11. Life expectancy >1 year

12. Rutherford classification of 2, 3 or 4.

Exclusion Criteria

1. Pregnant or lactating females.

2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.

3. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.

4. Known intolerance to study medications, everolimus or contrast agents.

5. Doubts in the willingness or capability of the subject to allow follow-up examinations.

6. Subject is actively participating in another investigational device or drug study.

7. History of hemorrhagic stroke within 3 months of procedure.

8. Previous or planned surgical or interventional procedure within 30 days of index procedure.

9. Prior vascular surgery of the target lesion.

10. 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.

11. Known inadequate distal outflow.

12. Significant inflow disease.

13. Acute or sub-acute thrombus in target vessel.

14. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).

15. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.

16. Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.

17. Rutherford classification of 0, 1, 5 or 6

18. Presence of prohibitive calcification that precludes adequate PTA treatment.

19. Subjects held in custody in an institution by official or court order.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Polyclinique Les Fleurs

Ollioules, , France

Hôpital Paris Saint Joseph

Paris, , France

Hôpital Nord Laennec - CHU de Nantes

Saint-Herblain, , France

Clinique Pasteur

Toulouse, , France

Institut für Radiologie, Kinderradiologie und interventionelle Therapie

Berlin, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

DIAKO Krankenhaus Flensburg

Flensburg, , Germany

Romed Klinikum Rosenheim

Rosenheim, , Germany

Countries

France; Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TP1109

Identifier Type: -

Identifier Source: org_study_id