A First-in-Man Study of IBS

NCT03509142 | Completed

• 1 other identifier: IBS-FIM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.

Conditions

Single Coronary Vessel Disease

Outcome Measures

Primary Outcomes (2)

• Study Device related Composite Endpoint (Target Lesion Failure)

  Target Lesion Failure is defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).

  6 months after implantation

• Late Lumen Loss

  Late Lumen Loss

  6 months after implantation

Secondary Outcomes (25)

• Immediate Success Rate

  Immediate post procedure

• Clinical Success

  Hospitalized period post procedure within 7 days

• Performance Evaluation of IBS

  Immediate post procedure

• Device related Composite Endpoint (DoCE)

  1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure

• Patient related Clinical Composite Endpoint (PoCE)

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

Study Arms (1)

IBS implantation

EXPERIMENTAL

Implantation of IBS in patients with coronary artery lesions. All the subjects will be assigned to cohort 1 (n=30) and cohort 2 (n=15).

Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

Interventions

Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System DEVICE

Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)

Also known as: IBS

IBS implantation

Eligibility Criteria

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

You may qualify if:

• All patients participating in this clinical trial must meet the following criteria:
• Age of 18-75, males or non pregnancy females;
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
• One target lesion, and target lesion can be completely covered by a single stent;
• Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
• Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
• Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

You may not qualify if:

• Patients will be excluded if any of the following conditions apply:
• General:
• Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
• Implantation of stent in target vessel within 1 year, patients with planned intervention again within six months;
• Patients who had coronary artery bypass (coronary artery bypass grafting);
• Patients with contraindications for coronary artery bypass graft surgery;
• Severe heart failure (NYHA class III and above) or left ventricular ejection fraction\<40% (ultrasonic or left ventricular angiography);
• Preoperative renal function: serum creatinine \> 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
• Patients had ischemic stroke half a year before implantation, patients had transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination;
• Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
• Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
• Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
• The patient's life expectancy is less than 12 months;
• Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
• Poor compliance and patients unable to complete the study in accordance with the requirements;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Beijing Fuwai hospital

Beijing, 100037, China

Location

Study Officials

• Runlin Gao

  Fu Wai Hospital, Beijing, China

  STUDY CHAIR

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: April 16, 2018
• First Posted: April 26, 2018
• Study Start: April 10, 2018
• Primary Completion: July 19, 2019
• Study Completion: December 10, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

CN (1)