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Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

NCT03380650 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-21

No results posted yet for this study

Summary

This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Conditions

Interventions

DEVICE

directional atherectomy and locol drug delivery

combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease

DEVICE

drug-coated balloon dilation

use of drug-coated balloon dilation for the treatment of femoralpopliteal disease

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Lan Zhang, M.D., Ph.D. · RenJi Hospital

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
2018-12-30
Completion
2019-12-30

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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 NCT03380650 on ClinicalTrials.gov