Not Yet RecruitingNot Applicable

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

200 participantsStarted 2024-12-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Primary patency

Timeframe: 12-month

Freedom from a composite of Major adverse events (MAEs)

Timeframe: 12-month

Trial details

NCT IDNCT06752954

SponsorFirst Affiliated Hospital of Jinan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Jiandong Guo

+8613420187264 407939203@qq.com

View on ClinicalTrials.gov More Peripheral Arterial Disease trials