- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734157
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
February 15, 2023 updated by: Chansu Vascular Technologies
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
Active, not recruiting
Conditions
Intervention / Treatment
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)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ollioules, France, 83190
- Polyclinique Les Fleurs
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Paris, France, 75014
- Hopital Paris Saint Joseph
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Saint-Herblain, France, 44800
- Hôpital Nord Laennec - CHU de Nantes
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Toulouse, France, 31300
- Clinique Pasteur
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Berlin, Germany, 12351
- Vivantes Klinikum Neukölln
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Berlin, Germany, 13347
- Jüdisches Krankenhaus Berlin
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Flensburg, Germany, 24939
- DIAKO Krankenhaus Flensburg
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Rosenheim, Germany, 83022
- RoMed Klinikum Rosenheim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject 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 who do not respond favorably to Exercise Therapy or with symptoms that impact significantly daily life, 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.
Exclusion Criteria:
- 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.
- Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
- Rutherford classification of 0, 1, 5 or 6
- Presence of prohibitive calcification that precludes adequate PTA treatment.
- Subjects held in custody in an institution by official or court order.
- Subject is not covered by any medical insurance coverage.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Everolimus-coated balloon
Treatment of occlusion or stenosis in Superficial Femoral Artery and Proximal Popliteal Artery with drug-coated balloon
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Peripheral artery angioplasty
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom of Major Adverse Event (MAE) rate
Time Frame: 6 months post-procedure
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Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
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6 months post-procedure
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Patency
Time Frame: 6 months post procedure
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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).
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6 months post procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of MAE
Time Frame: One year post-procedure
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Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
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One year post-procedure
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Patency
Time Frame: 12 months post procedure
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Freedom from clinically driven TLR and duplex ultrasonography detected restenosis (ultrasound peak systolic velocity ratio ≤ 2.4 or stenosis ≤50%)
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12 months post procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2022
Primary Completion (Actual)
February 3, 2023
Study Completion (Anticipated)
September 1, 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)
February 17, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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