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

Femoral Artery Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05734157
• Other study ID #: TP1109
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2023
• Source: Chansu Vascular Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: September 1, 2025
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject 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 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.

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.

20. Subject is not covered by any medical insurance coverage.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Constriction, Pathologic
• Femoral Artery Occlusion
• Femoral Artery Stenosis
• Popliteal Artery Occlusion
• Popliteal Artery Stenosis

Intervention

Device:
• Peripheral PTA with a drug coated balloon
Peripheral artery angioplasty

Locations

Country	Name	City	State
France	Polyclinique Les Fleurs	Ollioules
France	Hôpital Paris Saint Joseph	Paris
France	Hôpital Nord Laennec - CHU de Nantes	Saint-Herblain
France	Clinique Pasteur	Toulouse
Germany	Jüdisches Krankenhaus Berlin	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	DIAKO Krankenhaus Flensburg	Flensburg
Germany	Romed Klinikum Rosenheim	Rosenheim

Sponsors (1)

Lead Sponsor	Collaborator
Chansu Vascular Technologies

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patency	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	Rate of MAE	Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).	One year post-procedure
Secondary	Patency	Freedom from clinically driven TLR and duplex ultrasonography detected restenosis (ultrasound peak systolic velocity ratio = 2.4 or stenosis =50%)	12 months post procedure