A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

NCT03616132 | Unknown

• 1 other identifier: IBS-FIM-MY
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 (1)

• 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).

  1 month after implantation

Secondary Outcomes (14)

• Immediate Success Rate

  Immediate postoperative

• Clinical Success

  Hospitalized period postoperative within 7 days

• Performance Evaluation of IBS

  Immediate postoperative

• Device related Composite Endpoint (DoCE)

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

• Patient related Clinical Composite Endpoint (PoCE)

  30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure

Study Arms (1)

IBS implantation

EXPERIMENTAL

Implantation of IBS in patients with coronary artery lesions.

Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

Interventions

Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System DEVICE

Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (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 performed 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 have ischemic stroke half a year before implantation, patients have 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 (2)

Institut Jantung Negara

Kuala Lumpur, Negeri Selangor, Malaysia

NOT YET RECRUITING

University Malaya Medical Centre

Kuala Lumpur, Negeri Selangor, Malaysia

RECRUITING

Central Study Contacts

Ying Xia

CONTACT

+86 13760184511; 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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 6, 2018
• Study Start: March 28, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2023
• Last Updated: August 6, 2018

Record last verified: 2018-07

Locations

MY (2)