Single Coronary Vessel Disease
Conditions
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
Interventions
Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
All patients participating in this clinical trial must meet the following criteria: 1. Age of 18-75, males or non pregnancy females; 2. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI; 3. One target lesion, and target lesion can be completely covered by a single stent; 4. Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual); 5. Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1; 6. 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: General: 1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal; 2. Implantation of stent in target vessel within 1 year, patients with planned intervention again within six months; 3. Patients who had coronary artery bypass (coronary artery bypass grafting); 4. Patients with contraindications for coronary artery bypass graft surgery; 5. Severe heart failure (NYHA class III and above) or left ventricular ejection fraction\<40% (ultrasonic or left ventricular angiography); 6. Preoperative renal function: serum creatinine \> 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis; 7. 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; 8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy; 9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies; 10. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc; 11. The patient's life expectancy is less than 12 months; 12. Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame; 13. Poor compliance and patients unable to complete the study in accordance with the requirements; 14. Patient with heart transplant; 15. The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia; 16. Cancer needs chemotherapy; 17. Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy; 18. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc; 19. With six months for elective surgery requires stop using aspirin and clopidogrel; 20. Blood test prompted platelet count \< 100 x 10\^9/L, or \> 700 x 10\^9/L, white blood cells \< 3 x 10\^9/L, or abnormal liver function (ALT, AST 3 times greater than normal range); 21. Patients with diffuse peripheral vascular disease; cannot use 6F catheter; 22. Patients with valvular surgery in the past.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Device related Composite Endpoint (Target Lesion Failure) | 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). |
| Late Lumen Loss | 6 months after implantation | Late Lumen Loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Evaluation of IBS | Immediate post procedure | 4 class (Excellent, good, general, bad) to evaluate the push ability, performance of through the lesions, performance of cover the lesions, support force, withdraw ability. |
| Device related Composite Endpoint (DoCE) | 1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure | Target Lesion Failure, defined as the composited endpoints of including cardiac death, target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR). |
| Patient related Clinical Composite Endpoint (PoCE) | 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure | Including all-cause mortality, all myocardial infarction and any revascularization. |
| Stent Thrombosis defined by ARC | Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year) | Timing (acute, sub-acute, late and very late) Evidence (definite and probable) |
| Thickness of acute stent recoil (mm) | Immediate post procedure | Angiographic Endpoint |
| In-stent, in-segment, proximal and distal minimum lumen diameter (MLD) | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Angiographic Endpoint |
| In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %) | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Angiographic Endpoint |
| In-stent, in-segment, proximal and distal late lumen loss (LLL) | 1 year, 2 years, 3 years | Angiographic Endpoint |
| In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR) | 6 months, 1 year, 2 years, 3 years | Angiographic Endpoint |
| Vasomotion | 6 months,1 year, 2 years, 3 years | Defined as the average diameter change of lumen diameter before and after using nitroglycerin. |
| Analysis of neointimal thickness by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Immediate Success Rate | Immediate post procedure | 1. Device Success: Successfully transit and release the IBS at target lesion, then withdraw the delivery system. Immediate residual stenosis \< 30% and TIMI blood flow is class 3 (visual). 2. Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion \< 30% and TIMI blood flow is class 3(visual). |
| Analysis of incomplete strut apposition by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Analysis of percentage area obstruction by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Analysis of healing score by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Analysis of late recoil by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Analysis of vessel area by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of lumen area by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of scaffold area by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of neointimal area by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of percentage area obstruction by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of volumetric obstruction by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of late recoil area by IVUS | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Intra-Vascular Ultrasound Endpoint |
| Analysis of proportion of strut coverage by OCT | Immediate post procedure, 6 months, 1 year, 2 years, 3 years | Optical Coherence Tomography Endpoint |
| Clinical Success | Hospitalized period post procedure within 7 days | Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period. |
Countries
China
Outcome results
None listed