Trials / Recruiting
RecruitingNCT05971394
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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™) |
Timeline
- Start date
- 2023-07-17
- Primary completion
- 2026-01-01
- Completion
- 2026-07-01
- First posted
- 2023-08-02
- Last updated
- 2023-08-02
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05971394. Inclusion in this directory is not an endorsement.