UnknownNot Applicable

LDD in Treatment of Femoropopliteal ISR

China40 participantsStarted 2018-01-01

Plain-language summary

This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * have signed the informed consent * age of 18-80 years old * femoropopliteal artery disease (Rutherford 2-4) * femoropopliteal in-stent restenosis (≥70%) * length of lesion ≤ 20cm * at least one infrapopliteal run-off vessel Exclusion Criteria: * serum Cr \> 150 umol/L * patients with acute thrombosis * stent fracture within femoropopliteal artery * allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium * already recruited into other clinical trials that could influence the outcome of this study * pregnancy and lactation * relatively easy bleeding * malignancy or irreversible organ failure

What they're measuring

target lesion revascularization

Timeframe: 12 months

Trial details

NCT IDNCT03521843

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-30

Contact for this trial

Meng Ye, M.D., Ph.D.

+86 13817145123 13817145123@163.com

View on ClinicalTrials.gov More Peripheral Artery Disease trials