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RECRUITING
NCT05971394
NA

IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this prospective, multicentre, single arm clinical trial is 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. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.

Official title: A Prospective, Multicentre, Single Arm Clinical 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-07-17

Completion Date

2026-07

Last Updated

2023-08-02

Healthy Volunteers

No

Interventions

DEVICE

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

Subjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)

Locations (1)

Azienda Ospedaliero Universitaria Careggi

Florence, Italy