A Clinical Trial to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease

NCT05205499 | Active Not Recruiting DMC

• 1 other identifier: IBS III
• Study Type: interventional
• Target: 1,059
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multi-center, single-arm trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of target lesion failure

  Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  1 year

Secondary Outcomes (11)

• Rate of Device Success

  Immediately post-procedure

• Rate of Lesion Success

  Immediately post-procedure

• Rate of Clinical Success

  ≤ 7 days post the index procedure (In-hospital)

• Rate of Device-oriented Composite Endpoint (DoCE)

  1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

• Rate of Patient-oriented Composite Endpoint (PoCE)

  1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

Study Arms (1)

IBS

EXPERIMENTAL

Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System

Device: Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System

Interventions

Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System DEVICE

Subjects in this arm will be treated with IBS

IBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must between 18 and 75 years old, male or non-pregnant female.
• Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, silent myocardial ischemia, or acute myocardial infarction\> 1 week) suitable for elective PCI.
• One or two de novo target lesions each located in a different epicardial vessel.
• If there is one target lesion, another non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful result prior to registration of the subject.
• If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
• The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
• Lesion(s) must have a visually estimated length of ≤33mm, diameter between range of 2.5-4.0mm, and each lesion can be completely covered by a stent.
• Lesion(s) must have a visually estimated diameter stenosis of ≥70% (or ≥50% and have evidence of myocardial ischemia in this location) with a TIMI flow of ≥1
• Patient can understand the study purpose, voluntarily participate in the study, sign the informed consent, and willing to undergo 5-year follow-ups.

You may not qualify if:

• Patient had an acute myocardial infarction (AMI) or CK, CK-MB have not returned to within normal limits after myocardial infarction within 7 days of the index procedure.
• Patient has implanted stent in the target vessel within 1 year of the index procedure, or is scheduled to undergo re-intervention in the future 6 months.
• Patient with a history of coronary artery bypass (coronary artery bypass grafting).
• Patient with contraindications on coronary artery bypass graft surgery.
• Patient with severe heart failure (NYHA class ≥III) or left ventricular ejection fraction\<40% (by echocardiography or contrast left ventriculography).
• Patient with known renal insufficiency: serum creatinine \> 2.0 mg/dl or 177 μmol/L, or/and patient on dialysis.
• Patient with known hepatic insufficiency: ALT, AST ≥3 times the upper limit of normal.
• Patient had an ischemic stroke within 6 months or transient ischemic neurological attack (TIA) within 3 months before the index procedure, or has tendency of hypercoagulation as per investigator judgement or laboratory test.
• Patient with bleeding diathesis, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy, and unable to undergoing antithrombotic therapy.
• Patient with known allergy to aspirin, clopidogrel, heparin, contrast agent, PDLLA, sirolimus and metal (iron, zinc etc).
• Patient with a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
• Patient with life expectancy ≤1 years.
• Patient is already participating in another drug or medical device clinical trial that has not yet reached its primary endpoint.
• Patient with poor compliance and cannot comply with the protocol requirement as per investigator judgement.
• Subject has received a heart transplant.

Sponsors & Collaborators

• Biotyx Medical (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

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: December 20, 2021
• First Posted: January 25, 2022
• Study Start: March 10, 2022
• Primary Completion: July 1, 2024
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CN (1)