The Effectiveness of Covered Stent Viabahn and Drug-coated Balloon for Complex Femoropopliteal Artery Lesions

Comparison of the Effectiveness of Viabahn® Vs. Drug-Coated Balloon With/without Bail-Out Bare Metal Stent in Treating Complicated Femoropopliteal Lesions

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Drug-coated balloon group; Device: Viabahn endoprosthesis group

Detailed Description

This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients.

All enrolled patients will be followed up for 12 and 24 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, 3,6 and 9 months.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jiandong Guo; Phone Number: +8613420187264; Email: 407939203@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. The patient is ≥ 18 years old.
2. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
3. The patient is willing to comply with specified follow-up evaluations at the specified times.
4. The patient presented a score from 2 to 5 following Rutherford classification.
5. The patient has a projected life expectancy of at least 24 months
6. 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.

Description

Inclusion Criteria:

1. The patient is ≥ 18 years old.
2. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
3. The patient is willing to comply with specified follow-up evaluations at the specified times.
4. The patient presented a score from 2 to 5 following Rutherford classification.
5. The patient has a projected life expectancy of at least 24 months
6. 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.

Exclusion Criteria:

1. Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
2. Pregnant women or Female patients with potential childbearing
3. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
4. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
5. The patient is currently participating in another investigational drug or device study that interferes with the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Viabahn endoprosthesis group; Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.	Device: Viabahn endoprosthesis group; 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.	Device: Drug-coated balloon group; Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.	12-month
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	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success is defined as technical or device success without major adverse events during the hospital stay.	Immediately after interventional surgery
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.	12-month
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.	12-month
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.	12-month
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.	12-month
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.	12-month
Vasc quality of life score	Change of Vasc quality of life score	12-month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Jinan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Drug-coated balloon; Viabahn endoprosthesis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: The support study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No