A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Single Coronary Vessel Disease
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Study Device related Composite Endpoint (Target Lesion Failure)
- Last Updated
- 7 years ago
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, non-randomized trial * Study population: 15 patients * Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years; * All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years. * The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.
Investigators
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 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;
Outcomes
Primary Outcomes
Study Device related Composite Endpoint (Target Lesion Failure)
Time Frame: 1 month 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
- 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)
- Stent Thrombosis defined by ARC(Acute(0-24 hours), Subacute(24 hours-30 days), Late(30 days-1 year),Very late(after 1 year))
- Acute stent retraction(Immediate postoperative)
- In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)(Immediate postoperative, 1 year, 3 years)
- In-stent, in-segment, proximal and distal Diameter stenosis(DS)(1 year, 3 years)
- In-stent, in-segment, proximal and distal Late lumen loss (LLL)(1 year, 3 years)
- In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)(1 year, 3 years)
- Vasomotion(1 year, 3 years)
- Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT(: Immediate postoperative, 1 year, 3 years)
- Analysis of Vascular and scaffold morphology obtained with IVUS(Immediate postoperative,1 year, 3 years)