- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509142
A First-in-Man Study of IBS (IBS-FIM)
A First-in-Man Study of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Target lesion failure (TLF) at 6 months post procedure
- Late Lumen Loss at 6 months post procedure
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Peking, China, 100037
- Beijing Fuwai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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 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;
- 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;
- Patient with heart transplant;
- The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
- Cancer needs chemotherapy;
- Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
- Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
- With six months for elective surgery requires stop using aspirin and clopidogrel;
- 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);
- Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
- Patients with valvular surgery in the past.
Exclusion criteria by angiography:
- 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;
- Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
- In-stent restenosis;
- Myocardial bridge is involved in target lesion;
- In order to reach the target lesion, study stent has to go through the previous implanted stent;
- 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:
A.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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IBS implantation
Implantation of IBS in patients with coronary artery lesions.
All the subjects will be assigned to cohort 1 (n=30) and cohort 2 (n=15).
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Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study Device related Composite Endpoint (Target Lesion Failure)
Time Frame: 6 months after implantation
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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).
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6 months after implantation
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Late Lumen Loss
Time Frame: 6 months after implantation
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Late Lumen Loss
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6 months after implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate Success Rate
Time Frame: Immediate post procedure
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Immediate post procedure
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Clinical Success
Time Frame: Hospitalized period post procedure within 7 days
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Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.
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Hospitalized period post procedure within 7 days
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Performance Evaluation of IBS
Time Frame: Immediate post procedure
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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.
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Immediate post procedure
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Device related Composite Endpoint (DoCE)
Time Frame: 1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
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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).
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1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
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Patient related Clinical Composite Endpoint (PoCE)
Time Frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
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Including all-cause mortality, all myocardial infarction and any revascularization.
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1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
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Stent Thrombosis defined by ARC
Time Frame: Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year)
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Timing (acute, sub-acute, late and very late) Evidence (definite and probable)
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Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year)
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Thickness of acute stent recoil (mm)
Time Frame: Immediate post procedure
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Angiographic Endpoint
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Immediate post procedure
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In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Angiographic Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Angiographic Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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In-stent, in-segment, proximal and distal late lumen loss (LLL)
Time Frame: 1 year, 2 years, 3 years
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Angiographic Endpoint
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1 year, 2 years, 3 years
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In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)
Time Frame: 6 months, 1 year, 2 years, 3 years
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Angiographic Endpoint
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6 months, 1 year, 2 years, 3 years
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Vasomotion
Time Frame: 6 months,1 year, 2 years, 3 years
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Defined as the average diameter change of lumen diameter before and after using nitroglycerin.
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6 months,1 year, 2 years, 3 years
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Analysis of neointimal thickness by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of proportion of strut coverage by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of incomplete strut apposition by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of percentage area obstruction by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of healing score by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of late recoil by OCT
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Optical Coherence Tomography Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of vessel area by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of lumen area by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of scaffold area by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of neointimal area by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of percentage area obstruction by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of volumetric obstruction by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Analysis of late recoil area by IVUS
Time Frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Intra-Vascular Ultrasound Endpoint
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Immediate post procedure, 6 months, 1 year, 2 years, 3 years
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Collaborators and Investigators
Investigators
- Study Chair: Runlin Gao, Fu Wai Hospital, Beijing, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBS-FIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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