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

Biotyx Medical (Shenzhen) Co., Ltd.1 site in 1 country100 target enrollmentJuly 17, 2023

ConditionsInfrapopliteal Lesions Critical Limb Ischemia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Infrapopliteal Lesions
Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: Freedom from Primary Efficacy Failure
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 17, 2023

End Date

July 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotyx Medical (Shenzhen) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General criteria
•Subject between 18 and 85 years old.
•Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.
•Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-
•Subject requires primary treatment of de novo infrapopliteal lesions.
•Angiographic criteria
•Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.
•The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.
•The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.
•Only two infrapopliteal vessels are allowed to be treated at the same time.

Exclusion Criteria

•General criteria：
•Severe renal insufficiency, hepatic dysfunction (Cr \> 2 times normal limit or renal dialysis, ALT or AST \> 5 times normal limit).
•Major amputation before index procedure or plan for major amputation.
•Any coagulation disorder.
•Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
•Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.
•Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.
•Thromboangiitis obliterans (Buerger's disease).
•Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.
•Any surgery in target vessel before index procedure.

Outcomes

Primary Outcomes

Freedom from Primary Efficacy Failure

Time Frame: 6 months

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

Secondary Outcomes

Rate of Technical success(Immediately post-procedure)
Incidence of Target lesion restenosis(1 month, 6 months, 12 months)
Change in Rutherford Category compared to baseline (before treatment)(1 month, 6 months, 12 months)
Change in ankle-brachial index (ABI) compared to baseline (before treatment)(1 month, 6 months, 12 months)
Major adverse event (MAE)(1 month, 6 months, 12 months)
Rate of Device success(Immediately post-procedure)
Rate of Procedural success(Immediately post-procedure)