Trials / Unknown
UnknownNCT04849325
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A Prospective, Multi-Center, Randomized Trial Comparing the IBS Titan™ Sirolimus-Eluting Iron Bioresorbable Peripheral Scaffold System vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee Arteries: GENIUS TRIAL
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-09
- Primary completion
- 2024-04-01
- Completion
- 2024-10-01
- First posted
- 2021-04-19
- Last updated
- 2022-03-17
Locations
29 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04849325. Inclusion in this directory is not an endorsement.