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

NCT05971394 | Recruiting

• 1 other identifier: BTK-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infrapopliteal Lesions; Critical Limb Ischemia

Keywords

BTK; below-the-knee; Infrapopliteal lesions

Outcome Measures

Primary Outcomes (1)

• Freedom from Primary Efficacy Failure

  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.

  6 months

Secondary Outcomes (7)

• Major adverse event (MAE)

  1 month, 6 months, 12 months

• Rate of Device success

  Immediately post-procedure

• Rate of Technical success

  Immediately post-procedure

• Rate of Procedural success

  Immediately post-procedure

• Incidence of Target lesion restenosis

  1 month, 6 months, 12 months

Study Arms (1)

IBS Titan

EXPERIMENTAL

Subjects treated with IBS Titan™.Participants will be included in this arm.

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

Interventions

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

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

IBS Titan

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3-5.
• 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.
• A maximum of two stents can be deployed at one target vessel.
• There must be at least one unimpaired artery (\< 30% stenosis) to the ankle.

You may not qualify if:

• 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.
• Thromboangiitis obliterans (Buerger's disease).
• Any surgery in target vessel before index procedure.
• Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.
• Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Women of child-bearing potential not using an effective contraception; pregnant or lactating women.
• Subject is not suitable to participate in the trial as per investigators discretion.
• Life expectancy ≤ 12 months as per investigators judgement.
• Angiographic criteria
• The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis \>30% with or without intervention.

Sponsors & Collaborators

• Biotyx Medical (Shenzhen) Co., Ltd.: lead
• VascuScience GmbH: collaborator
• Mediolanum Cardio Research Srl: collaborator
• Euroimage Research Srl: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Ying Xia

CONTACT

0755 23221096; xiaying@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: August 2, 2023
• Study Start: July 17, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

IT (1)