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

NCT05734157 | Completed Results

• 1 other identifier: TP1109
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 8

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.

Conditions

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

Keywords

TP1109; CVT-SFA; Femoral Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate

  Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).

  6 months post procedure

• The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)

  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).

  6 months post procedure

Secondary Outcomes (24)

• Rate of Major Adverse Event (MAE)

  In Hospital

• Rate of Major Adverse Event (MAE)

  30 Days Post-procedure

• Rate of Major Adverse Event (MAE)

  12 months Post-procedure

• Rate of Occurrence of Arterial Thrombosis of the Treated Segment

  12months

• Rate of Ipsilateral Embolic Events of the Study Limb

  12 months

Study Arms (1)

Everolimus-coated balloon

EXPERIMENTAL

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

Device: Peripheral PTA with a drug coated balloon

Interventions

Peripheral PTA with a drug coated balloon DEVICE

Peripheral artery angioplasty

Everolimus-coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age.
• 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.
• Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.
• Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.
• 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.
• Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.
• Successful wire crossing of lesion.
• Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).
• Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.
• At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.
• Life expectancy \>1 year
• Rutherford classification of 2, 3 or 4.

You may not qualify if:

• Pregnant or lactating females.
• Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Known intolerance to study medications, everolimus or contrast agents.
• Doubts in the willingness or capability of the subject to allow follow-up examinations.
• Subject is actively participating in another investigational device or drug study.
• History of hemorrhagic stroke within 3 months of procedure.
• Previous or planned surgical or interventional procedure within 30 days of index procedure.
• Prior vascular surgery of the target lesion.
• 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.
• Known inadequate distal outflow.
• Significant inflow disease.
• Acute or sub-acute thrombus in target vessel.
• Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).
• Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (8)

Polyclinique Les Fleurs

Ollioules, 83190, France

Location

Hôpital Paris Saint Joseph

Paris, 75014, France

Location

Hôpital Nord Laennec - CHU de Nantes

Saint-Herblain, 44800, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Institut für Radiologie, Kinderradiologie und interventionelle Therapie

Berlin, 12351, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

Location

DIAKO Krankenhaus Flensburg

Flensburg, 24939, Germany

Location

Romed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Results Point of Contact

• Title: Krista Stiefel, Principal Clinical Scientist
• Organization: Abbott

krista.stiefel@abbott.com

+12246689359

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 17, 2023
• Study Start: February 17, 2022
• Primary Completion: September 11, 2023
• Study Completion: August 27, 2025
• Last Updated: September 19, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); FR (4)