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

Biotyx Medical (Shenzhen) Co., Ltd.29 sites in 1 country120 target enrollmentDecember 9, 2021

ConditionsCritical Limb Ischemia (CLI)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia (CLI)
Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.
Enrollment: 120
Locations: 29
Primary Endpoint: Primary Patency Rate
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 9, 2021

End Date

October 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotyx Medical (Shenzhen) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must between 18 and 85 years old, without gender limit.
•Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and complete the 1-year follow-up.
•Subject has lower extremity atherosclerotic occlusive disease with symptomatic Critical Limb Ischemia (CLI).
•Rutherford Becker Clinical Category 3-
•The target lesion is below the popliteal artery (including bifurcation).
•The target lesion is located in the proximal 2/3 of native infrapopliteal vessels or tibiofibular trunk.
•The target lesion stenosis is ≥70% or occlusion of no more than two infrapopliteal arteries (including the anterior and/or posterior tibial and/or peroneal artery and/or tibiofibular trunk).
•The length of target lesion is ≤200mm, which could be covered by no more than two stents, with vessel diameter of 2.25-4.25 mm.

Exclusion Criteria

•Severe renal insufficiency, hepatic dysfunction (Cr\>2 times of normal limit or renal dialysis, ALT or AST \> 5 times of normal limit).
•Surgery in target vessel before treatment.
•Volume reduction surgery in target vessel before treatment.
•Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
•Systematic coagulation disorder or hypercoagulability.
•Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
•Stroke occurs within 3 months before surgery, or stroke occurs with severe hemiplegia aphasia sequelae more than 3 months before treatment.
•Acute myocardial infarction or angina pectoris within 30 days before treatment.
•In-stent restenosis.
•Guide wire cannot pass target lesion.

Outcomes

Primary Outcomes

Primary Patency Rate

Time Frame: 180 days

Defined as freedom from total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR) of target lesion, and freedom from major amputation.

Secondary Outcomes

All-cause mortality(30 days, 180 days, 365 days)
Incidence of Target lesion restenosis(30 days, 180 days, 365 days)
Change in ankle-brachial index (ABI) compared to baseline (before treatment)(30 days, 180 days, 365 days)
Incidence of major amputation(30 days, 180 days, 365 days)
Rate of Device Success(Immediately after the procedure)
Rate of Participants with Technical Success(Immediately after the procedure)
Rate of Participants with Procedural Success(Immediately after the procedure)
Wound healing rate of ulcer patients(30 days, 180 days, 365 days)
Late Lumen Loss(180 days)
Change in Rutherford-Becker category compared to baseline (before treatment)(30 days, 180 days, 365 days)
Incidence of Clinically-driven Target Vessel Revascularization (CD-TLR)(30 days, 180 days, 365 days)