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LDD in Treatment of Femoropopliteal ISR

NCT03521843 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-05-11

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

balloon dilation only

The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.

DEVICE

balloon dilation+local drug delivery

The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-04-30
Completion
2019-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521843 on ClinicalTrials.gov