A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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A prospective, non-randomized trial
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Study population: 15 patients
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Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years;
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All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBS implantation Implantation of IBS in patients with coronary artery lesions. |
Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
|
Outcome Measures
Primary Outcome Measures
- Study Device related Composite Endpoint (Target Lesion Failure) [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 Outcome Measures
- Immediate Success Rate [Immediate postoperative]
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). Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion < 30% and TIMI blood flow is class 3(visual).
- Clinical Success [Hospitalized period postoperative within 7 days]
Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.
- Performance Evaluation of IBS [Immediate postoperative]
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) [6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure]
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), also known as MACE (major adverse cardiac events).
- Patient related Clinical Composite Endpoint (PoCE) [30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure]
Including all-cause mortality, all myocardial infarction and target lesion 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)
- Acute stent retraction [Immediate postoperative]
Angiographic Endpoint
- In-stent, in-segment, proximal and distal minimum lumen diameter (MLD) [Immediate postoperative, 1 year, 3 years]
Angiographic Endpoint
- In-stent, in-segment, proximal and distal Diameter stenosis(DS) [1 year, 3 years]
Angiographic Endpoint
- In-stent, in-segment, proximal and distal Late lumen loss (LLL) [1 year, 3 years]
Angiographic Endpoint
- In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR) [1 year, 3 years]
Angiographic Endpoint
- Vasomotion [1 year, 3 years]
Defined as the average diameter change of lumen diameter before and after using nitroglycerin.
- Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT [: Immediate postoperative, 1 year, 3 years]
Optical Coherence Tomography Endpoint
- Analysis of Vascular and scaffold morphology obtained with IVUS [Immediate postoperative,1 year, 3 years]
Intra-Vascular Ultrasound Endpoint
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients participating in this clinical trial must meet the following criteria:
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Age of 18-75， males or non pregnancy females;
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Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
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One target lesion, and target lesion can be completely covered by a single stent;
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Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
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Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
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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:
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Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
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Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
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Patients who performed coronary artery bypass (coronary artery bypass grafting);
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Patients with contraindications for coronary artery bypass graft surgery;
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Severe heart failure (NYHA class III and above) or left ventricular ejection fraction<40% (ultrasonic or left ventricular angiography);
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Preoperative renal function: serum creatinine > 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
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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;
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Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
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Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
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Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
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The patient's life expectancy is less than 12 months;
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Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
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Poor compliance and patients unable to complete the study in accordance with the requirements;
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Patient with heart transplant;
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The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
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Cancer needs chemotherapy;
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Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
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Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
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With six months for elective surgery requires stop using aspirin and clopidogrel;
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Blood test prompted platelet count < 100 x 109/L, or > 700 x 109/L, white blood cells < 3 x 109/L, or abnormal liver function (ALT、AST 3 times greater than normal range);
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Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
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Patients with valvular surgery in the past.
Exclusion criteria by angiography:
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Chronic total occlusion (TIMI blood flow=0 before implantation) , left main coronary artery lesion, ostial lesion, multiple vessel lesion, branch lesion and bridge lesion which branch vessel diameter ≥ 2.0 mm (if the ostium of branch vessel stenosis >40% or needs balloon predilation); visible thrombus in target vessels;
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Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
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In-stent restenosis;
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Myocardial bridge is involved in target lesion;
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In order to reach the target lesion, study stent has to go through the previous implanted stent;
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Predilation balloon can't expand completely in target lesion site, judgment standard for fully expansion as below, patients are excluded when do not meet any item:
- DS% < 40%（visual），highly recommend DS% ≤20% B. TIMI blood flow= class 3（visual） C. No angiography complications (e.g., distal embolization, lateral branch closed) D. No interlining level NHLBI type D - F E. No continuous chest pain (> 5 minutes), and F. No lower or higher ST segment >5 minutes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Jantung Negara | Kuala Lumpur | Negeri Selangor | Malaysia | |
| 2 | University Malaya Medical Centre | Kuala Lumpur | Negeri Selangor | Malaysia |
Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBS-FIM-MY