A Prospective, Single-Center, First-in-Man Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-I

Lifetech Scientific (Shenzhen) Co., Ltd.1 site in 1 country45 target enrollmentApril 10, 2018

ConditionsSingle Coronary Vessel Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Single Coronary Vessel Disease
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Enrollment: 45
Locations: 1
Primary Endpoint: Late Lumen Loss
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

A prospective, single-center, First-in-Man trial; Study population: 45 subjects. 45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 2(n=15) The clinical follow up will be performed in all subjects at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years post procedure; The Angiographic, Intra-Vascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be performed at 6 months and 2 years post procedure in cohort 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in cohort 2. The primary study endpoints: 1. Target lesion failure (TLF) at 6 months post procedure 2. Late Lumen Loss at 6 months post procedure

Registry

clinicaltrials.gov

Start Date

April 10, 2018

End Date

December 10, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Patients will be excluded if any of the following conditions apply:
•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;

Outcomes

Primary Outcomes

Late Lumen Loss

Time Frame: 6 months after implantation

Late Lumen Loss

Study Device related Composite Endpoint (Target Lesion Failure)

Time Frame: 6 months after implantation

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).

Secondary Outcomes

Analysis of percentage area obstruction by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of healing score by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of vessel area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of scaffold area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of percentage area obstruction by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
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)
In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of incomplete strut apposition by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of lumen area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Immediate Success Rate(Immediate post procedure)
Stent Thrombosis defined by ARC(Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year))
Analysis of proportion of strut coverage by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of neointimal area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Clinical Success(Hospitalized period post procedure within 7 days)
Patient related Clinical Composite Endpoint (PoCE)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure)
In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)(6 months, 1 year, 2 years, 3 years)
Analysis of neointimal thickness by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of volumetric obstruction by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Analysis of late recoil area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
Thickness of acute stent recoil (mm)(Immediate post procedure)
In-stent, in-segment, proximal and distal late lumen loss (LLL)(1 year, 2 years, 3 years)
Vasomotion(6 months,1 year, 2 years, 3 years)
Analysis of late recoil by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)