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

Not Applicable

Active, not recruiting

• Conditions: Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion

• Registration Number: NCT05734157
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2022-02-17
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-17
• Primary Completion: 2023-09-11
• Results First Submitted: 2024-12-01
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Participants With 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).
The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)	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

Name	Time	Method
Rate of Major Adverse Event (MAE)	12 months Post-procedure	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	12months	Rate of occurrence arterial thrombosis of the treated segment as determined by QVA
Rate of Ipsilateral Embolic Events of the Study Limb	12 months	This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.
Rate of Clinically-driven Revascularization	12 months	This end point was to asses the Rate of Clinically-driven Revascularization.
Patency Rate	12 months	The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.
Rate of Vascular Access Site Complication	12 months	Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.
Lesion Success	12 months	Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.
Technical Success	12 months	Technical success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using the CVT Everolimus-coated PTA Catheter without a device malfunction after wire passage through the lesion. Pre- and postdilatation are considered part of assigned device treatment.
Clinical Success	12 months	Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.
Procedural Success	12 months	Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.
Change in Ankle-Brachial Index (ABI)	12 months	Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty	Pre-Procedure to 6 months and 12 months	The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on degree of difficulty, according to approximate number of feet, stairs, or miles per hour for distance, stair-climbing, and speed scores, respectively. Scores are then divided by maximum number of points and presented on a scale of 0% to 100%, where 0% represents lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less difficulty with walking, while a lower score signifies greater difficulty with walking.
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed	Pre-Procedure to 6 months and 12 months	The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). Higher scores signify less difficulty in maintaining speed while walking.
Walking Test: Change in Walking Distance	Baseline to 6 months and 12 months	The Walking Test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Treadmill Test: Change in Walking Distance	Baseline to 6 months and 12 months	Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).
Change in Rutherford Classification	12 months	Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.; Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value.; Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg.; Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg.; Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment	Pre-Procedure to 6 months and 12 months	The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less perceived walking impairment.

Trial Locations

Locations (8)

Institut für Radiologie, Kinderradiologie und interventionelle Therapie; 🇩🇪 Berlin, Germany

Polyclinique Les Fleurs; 🇫🇷 Ollioules, France

Hôpital Paris Saint Joseph; 🇫🇷 Paris, France

Hôpital Nord Laennec - CHU de Nantes; 🇫🇷 Saint-Herblain, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Jüdisches Krankenhaus Berlin; 🇩🇪 Berlin, Germany

DIAKO Krankenhaus Flensburg; 🇩🇪 Flensburg, Germany

Romed Klinikum Rosenheim; 🇩🇪 Rosenheim, Germany