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Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease

NCT02772224 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2016-05-13

No results posted yet for this study

Summary

Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Drug eluting balloon angioplasty

In the DEB group, the guide wire will be passed through the occluded or stenosed lumen and the predilatation of the target lesion with standard balloon(s) will be performed before dilatation with a paclitaxel-eluting balloon of the diameter, at least about that of the pre-dilatation balloon (Arteryguard, Rientech, Dezhou, China). The drug eluting balloons will then be inflated according to the manufacturer recommendations. The patients will then be followed every six months for a year to compare its treatment efficacy and safety with that of conventional balloon angioplasty group.

DEVICE

Conventional balloon angioplasty

The guide wire will be passed through the occluded or stenosed lumen and the conventional balloons will be inflated as recommended by the manufacturer. The primary and secondary outcome will then be assessed and compared with DEB group, on follow up at six and 12 months.

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • China

Study Locations

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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 NCT02772224 on ClinicalTrials.gov