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IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease

NCT04849325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-17

No results posted yet for this study

Summary

A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease.

Conditions

  • Critical Limb Ischemia (CLI)

Interventions

DEVICE

Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)

Subjects in this arm will be treated with IBS Titan™.

DEVICE

Percutaneous Transluminal Angioplasty (PTA) Device

Subjects in this arm will be treated with PTA device.

Sponsors & Collaborators

  • Biotyx Medical (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2024-04-30
Completion
2024-10-31

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 NCT04849325 on ClinicalTrials.gov