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

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.

Study Overview

• Status: Completed
• Conditions: Popliteal Artery Stenosis; Popliteal Artery Occlusion; Femoral Artery Occlusion; Femoral Artery Stenosis
• Intervention / Treatment: Device: Peripheral PTA with a drug coated balloon

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ollioules, France, 83190
    • Polyclinique Les Fleurs
  • Paris, France, 75014
    • Hôpital Paris Saint Joseph
  • Saint-Herblain, France, 44800
    • Hôpital Nord Laennec - CHU de Nantes
  • Toulouse, France, 31300
    • Clinique Pasteur
• Germany
  • Berlin, Germany, 13347
    • Judisches Krankenhaus Berlin
  • Berlin, Germany, 12351
    • Institut für Radiologie, Kinderradiologie und interventionelle Therapie
  • Flensburg, Germany, 24939
    • DIAKO Krankenhaus Flensburg
  • Rosenheim, Germany, 83022
    • RoMed Klinikum Rosenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Peripheral PTA with a drug coated balloon; Peripheral artery angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate	Freedom from MAEs defined as a composite rate of cardiovascular death, index limb amputation, and ischemia-driven TLR.	6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Adverse Event (MAE)	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). The time frame for "In hospital" refers to time from procedure to discharge. This timeframe is different for every enrolled subject. The subject is discharged at the treating physician's discretion based on their specific treatment needs.	In Hospital
Rate of Major Adverse Event (MAE)	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).	30 Days Post-procedure
Rate of Major Adverse Event (MAE)	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).	12 months Post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	Rate of occurrence arterial thrombosis of the treated segment as determined by QVA	12months
Rate of Ipsilateral Embolic Events of the Study Limb	This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.	12 months
Patency Rate	The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.	12 months
Rate of Vascular Access Site Complication	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.	12 months
Lesion Success	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.	12 months
Technical Success	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.	12 months
Clinical Success	Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.	12 months
Procedural Success	Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.	12 months
Change in Ankle-Brachial Index (ABI)	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.	Discharge
Change in Ankle-Brachial Index (ABI)	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.	6 months
Change in Ankle-Brachial Index (ABI)	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.	12 months
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty	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.	Pre-Procedure to 6 months and 12 months
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed	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.	Pre-Procedure to 6 months and 12 months
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment	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.	Pre-Procedure to 6 months and 12 months
Walking Test: Change in Walking Distance	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.	Baseline to 6 months and 12 months
Treadmill Test: Change in Walking Distance	Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).	Baseline to 6 months and 12 months
Change in Rutherford Classification	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.	Pre-procedure
Change in Rutherford Classification	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.	6 months
Change in Rutherford Classification	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.	12 months
Rate of Major Adverse Event (MAE)	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).	24months
Rate of Major Adverse Event (MAE)	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).	36months
Rate of Clinically-driven Target Lesion Revascularization	This end point was to asses the Rate of Clinically-driven Revascularization.	6 months
Rate of Clinically-driven Target Lesion Revascularization	This end point was to asses the Rate of Clinically-driven Revascularization.	12 months
Rate of Clinically-driven Target Lesion Revascularization	This end point was to asses the Rate of Clinically-driven Revascularization.	24 months
Rate of Clinically-driven Target Lesion Revascularization	This end point was to asses the Rate of Clinically-driven Revascularization.	36 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Femoral Artery Stenosis; TP1109; CVT-SFA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Arterial Occlusive Diseases
• Other Study ID Numbers: TP1109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No