The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions

Peripheral Arterial Disease Clinical Trial

Official title:

Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124755
• Other study ID #: The Virtue study
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Qihong Ni, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

Description:

This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient presented a score from 2 to 5 following Rutherford classification.

2. The patient is willing to comply with specified follow-up evaluations at the specified times.

3. The patient is = 18 years old.

4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study

5. The patient has a projected life expectancy of at least 24 months

6. Before enrolment, the guidewire has crossed the target lesion

7. Subject has a de novo or restenotic lesion with = 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length = 25cm, or chronic total occlusion (CTO) length =15cm.

8. There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.

9. Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.

10. Reference vessel diameter (RVD) = 4 mm by visual estimation.

Exclusion Criteria:

1. Previous bypass surgery or stenting in the target vessel

2. Patients who exhibit acute intraluminal thrombus at the target lesion vessel

3. Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy

4. Pregnant women or Female patients with potential childbearing

5. Use of thrombectomy, atherectomy, or laser devices during the procedure

6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)

7. The patient is currently participating in another investigational drug or device study that interferes with the study

8. Significant renal dysfunction (Serum creatinine >3.0mg/dl)

9. Patient with Known allergy to contrast media

10. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.

11. Femoral or popliteal aneurysm.

12. Current peritoneal or hemodialysis.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Viabahn endoprosthesis group
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
• Drug-coated balloon group
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor	Collaborator
RenJi Hospital	Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, Fudan University, Huashan Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Qingdao Haici Hospital, Second Affiliated Hospital of Soochow University, Xiamen Cardiovascular Hospital, Xiamen University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Peak systolic velocity ratio (PSVR =2.4) without any repeat intervention.	24-month
Primary	Freedom from a composite of Major adverse events (MAEs)	Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death	24-month
Secondary	Procedural success	Procedural success is defined as technical or device success without major adverse events during the hospital stay.	Immediately after interventional surgery
Secondary	Primary assisted patency	Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.	24-month
Secondary	Secondary patency	Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.	24-month
Secondary	Clinically-driven target vessel revascularization (CD-TVR)	clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.	24-month
Secondary	Primary sustained clinical improvement	Defined as a sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.	24-month
Secondary	Secondary sustained clinical improvement	Defined as a sustained upward shift of at least one category on the Rutherford classification3, including the need for repeated target lesion revascularization (TLR) in surviving patients.	24-month
Secondary	Vasc quality of life score	Change of Vasc quality of life score	24-month