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

NCT06752954 | Not Yet Recruiting DMC

• 1 other identifier: The support study
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

Viabahn endoprosthesis; Drug-coated balloon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Procedural success

  Immediately after interventional surgery

• Primary assisted patency

  12-month

• Secondary patency

  12-month

• Clinically-driven target vessel revascularization (CD-TVR)

  12-month

• Primary sustained clinical improvement

  12-month

Study Arms (2)

Viabahn endoprosthesis group

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.

Device: Viabahn endoprosthesis group

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

Interventions

Viabahn endoprosthesis group DEVICE

Viabahn endoprosthesis group：Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.

Viabahn endoprosthesis group

Drug-coated balloon group DEVICE

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Drug-coated balloon group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Jiandong Guo

CONTACT

+8613420187264; 407939203@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: December 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 31, 2024

Record last verified: 2024-11