- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890160
A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II (FUTURE-II)
A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Runlin Gao, MD
Study Locations
-
-
Beijing
-
Peking, Beijing, China, 100037
- Fu Wai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
General 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;
- 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.
Angiographic Inclusion Criteria:
One or two de novo target lesions:
- If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
- If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
- The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
- Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤4.0 mm. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 25 mm.
- Each target lesion may be covered with one stent.
General 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 III and above) ,or left ventricular ejection fraction <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.
Angiographic Exclusion Criteria:
- left main coronary artery disease;
- severe triple vessel lesion and required revascularization.
The following exclusion criteria apply to the target lesion(s) or target vessel(s):
- Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
- Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
Lesion involving a bifurcation with a:
- side branch ≥ 2.5 mm in diameter, or
- side branch with diameter stenosis ≥ 50%, or
- side branch requiring guide wire, or
- side branch requiring dilatation.
Anatomy proximal to or within the lesion that may impair delivery of Firesorb or XIENCE stent:
- Extreme angulation (≥ 90°) proximal to or within the target lesion.
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Moderate or heavy calcification proximal to or within the target lesion.
- Lesion or vessel involves a myocardial bridge.
- Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
- Vessel has been previously treated with a stent at any time prior to the index procedure such that the Firesorb or XIENCE would need to cross the stent to reach the target lesion.
- Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
- Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
- TIMI Grade-3 flow (per visual estimation).
- No angiographic complications (e.g. distal embolization, side branch closure).
- No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
- No chest pain lasting > 5 minutes.
- No ST depression or elevation lasting > 5 minutes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Firesorb
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)
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Sirolimus Target Eluting Bioresorbable Vascular Scaffold
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Active Comparator: XIENCE
Implantation of the XIENCE Everolimus Eluting Coronary Stent System
|
Everolimus Eluting Coronary Stent System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-segment Late Lumen Loss (LLL) (Queue 1)
Time Frame: 1 year after index procedure
|
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5mm proximal and 5mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
|
1 year after index procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of intima coverage-strut (OCT subgroup)
Time Frame: 1 year after index procedure
|
The main secondary endpoint
|
1 year after index procedure
|
Vasomotion (Queue 2)
Time Frame: 2 year after index procedure
|
The changes in average lumen diameter before and after intracoronary nitroglycerin
|
2 year after index procedure
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Acute Success-Device Success
Time Frame: From the start of index procedure to end of index procedure
|
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.
|
From the start of index procedure to end of index procedure
|
Acute Success-Procedural Success
Time Frame: At time of procedure up to 7 days in hospital
|
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.
|
At time of procedure up to 7 days in hospital
|
Device-oriented composite endpoints (Target Lesion Failure)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.
|
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 (PoCE)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Cardiac death (CD): Any death due to proximate cardiac cause (e.g.
MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Myocardial Infarction (MI)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Target Vessel Revascularization (TVR)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Target Lesion Revascularization (TLR)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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Any Revascularization
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
|
Scaffold/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
|
Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable)
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Site Diagnosed Angina (SDA)
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Defined as the study unit by collecting Seattle angina questionnaire (SAQ), doctor angina questionnaire and research units of AE reports incidence of angina pectoris (excludes angina pectoris 0-7 days after index procedure ).
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Minimum Lumen Diameter (MLD)
Time Frame: 1 year and 2 years after index procedure
|
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
|
1 year and 2 years after index procedure
|
percentage of diameter stenosis (%DS)
Time Frame: 1 year and 2 years after index procedure
|
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
|
1 year and 2 years after index procedure
|
Angiographic Binary Restenosis (ABR)
Time Frame: 1 year and 2 years after index procedure
|
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
|
1 year and 2 years after index procedure
|
Late Lumen Loss (LLL)
Time Frame: 1 year and 2 years after index procedure
|
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
|
1 year and 2 years after index procedure
|
Acute Stent Recoil
Time Frame: Immediately after index procedure
|
Immediately after index procedure
|
|
Descriptive analysis of morphometric, lesion composition and scaffold strut data obtained with OCT
Time Frame: 1 year and 2 years after index procedure
|
OCT endpoint
|
1 year and 2 years after index procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Runlin Gao, MD, Fu Wai Hospital & National Center for Cardiovascular Diseases in China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MicroPort_Firesorb_RCT
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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