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CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery | Clinical Trials | Clareo Health

COMPLETEDNA

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

Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation

NCT05734157•Abbott Medical Devices

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+9 more criteria

Locations (8)

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

Key Dates

Start Date

February 17, 2022

Primary Completion Date

September 11, 2023

Completion Date

August 27, 2025

Last Updated

September 19, 2025

Enrollment

ACTUAL participants

Conditions

Femoral Artery StenosisPopliteal Artery StenosisFemoral Artery OcclusionPopliteal Artery Occlusion

Interventions

Peripheral PTA with a drug coated balloon

DEVICE

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

NCT07338890

Superficial Femoral Artery StenosisIliac Artery Stenosis+1 more

View study

COMPLETED

VFI in Healthy Vessels

NCT05451485

Carotid Artery StenosisSuperficial Femoral Artery Stenosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

VFI in Healthy Vessels

A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.

Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D

CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")