- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659254
A First-in-Man Study of the Firesorb BVS (FUTURE-I) (FUTURE-I)
October 23, 2023 updated by: Shanghai MicroPort Medical (Group) Co., Ltd.
A First-in-Man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-I
This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time.
The goal is to access the preliminary safety and efficacy of Firesorb implantation in the human body, and to provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials.
Then provide the basis for the formal application of the product in China.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, single-center clinical trial.
The investigator design to recruit 45 subjects.
After implanting the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) successfully, all the subjects will be randomly assigned to queue 1 (n=30) and queue 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 and 5 years after scaffold implantation.
Angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after scaffold implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after scaffold implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after scaffold implantation, the secondary endpoints are series of imaging outcomes, for evaluation of feasibility and preliminary safety and efficacy of the product.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Peking, Beijing, China, 100037
- Fu Wai Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-75 years of age, males or non-pregnant females;
- With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- Total number of target lesion is 1;
- Target lesion length ≤ 25mm (Visual); target lesion diameter between 3.0mm to 3.5mm;
- Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
- Each target lesion may be covered by a single stent;
- Patients with indications for coronary artery bypass graft surgery;
- To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Exclusion Criteria:
- 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;
- Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
- Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
- Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
- Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
- The patient's life expectancy is less than 12 months;
- Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
- Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
- Heart transplantation patients;
- The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
- Cancer need chemotherapy;
- Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
- Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
- Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
- Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis);
- Peripheral vascular disease, 6F catheter is not available.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: Firesorb Implantation
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)in patients with coronary artery lesions.
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Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device-oriented composite endpoints (Target Lesion Failure)
Time Frame: 1 month after index procedure
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Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.
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1 month after index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-oriented clinical composite endpoint (PoCE)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.
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1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Target Lesion Failure
Time Frame: 6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.
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6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Device Success
Time Frame: From the start of index procedure to end of index procedure
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Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by visual.
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From the start of index procedure to end of index procedure
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Procedural Success
Time Frame: At time of procedure up to 7 days in hospital
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Achievement of final in-scaffold/stent residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR.
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At time of procedure up to 7 days in hospital
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Scaffold Thrombosis/Stent Thrombosis (per ARC definition)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Timing (acute, sub-acute, late and very late) Evidence (definite and probable)
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1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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In-device, in-segment, proximal and distal minimum lumen diameter (MLD)
Time Frame: 6 months,1 year,2 years and 3 years after index procedure
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Angiographic endpoint.
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6 months,1 year,2 years and 3 years after index procedure
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In-device, in-segment, proximal and distal % diameter stenosis (DS)
Time Frame: 6 months,1 year,2 years and 3 years after index procedure
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Angiographic endpoint.
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6 months,1 year,2 years and 3 years after index procedure
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In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)
Time Frame: 6 months,1 year,2 years and 3 years after index procedure
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Angiographic endpoint.
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6 months,1 year,2 years and 3 years after index procedure
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In-device, in-segment,proximal and distal late lumen loss (LLL)
Time Frame: 6 months,1 year,2 years and 3 years after index procedur
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Angiographic endpoint.
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6 months,1 year,2 years and 3 years after index procedur
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Vasomotion
Time Frame: 6 months,1 year,2 years and 3 years after index procedure
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The changes in average lumen diameter before and after intracoronary nitroglycerin.
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6 months,1 year,2 years and 3 years after index procedure
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive analysis of morphometric, lesion composition and scaffold strut data obtained with OCT
Time Frame: Immediate,6 months,1 year,2 years and 3 years after index procedure
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OCT endpoint.
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Immediate,6 months,1 year,2 years and 3 years after index procedure
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Descriptive analysis of vascular and scaffold morphology obtained with IVUS
Time Frame: 6 months,1 year,2 years and 3 years after index procedure
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IVUS endpoint.
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6 months,1 year,2 years and 3 years after index procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Runlin Gao, MD, Fu Wai Hospital & National Center for Cardiovascular Diseases in China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
January 15, 2016
First Submitted That Met QC Criteria
January 19, 2016
First Posted (Estimated)
January 20, 2016
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 23, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- MicroPort_Firesorb_FIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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