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To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

NCT05662618 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2022-12-22

No results posted yet for this study

Summary

A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.

Conditions

  • Peripheral Arterial Disease

Interventions

PROCEDURE

Percutaneous selective arteriography of peripheral arteries

Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.

PROCEDURE

Percutaneous selective arteriography of peripheral arteries

Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.

Sponsors & Collaborators

  • Shanghai Bomaian Medical Technology Co., Ltd

    lead INDUSTRY

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
2022-12-31
Primary Completion
2025-06-30
Completion
2025-06-30

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 NCT05662618 on ClinicalTrials.gov