- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660202
Trial for MicroPort's Firesorb BVS: FUTURE-III (FUTURE-III)
A Prospective Multicenter Single-arm Clinical Trial Assessing the Safety and Effectiveness of Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold for the Treatment of Coronary Artery Disease: FUTURE III
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Peking, Beijing, China, 100037
- Fu Wai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
General Specification Subgroup:
- One or two de novo target lesions:
If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
Note: 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.
b. Target lesion(s) must be located in a native coronary artery with a visually estimated stenosis ≥ 70% or ≥ 50% and < 100% with clinical evidence of myocardial ischemia, a thrombolysis in myocardial infarction (TIMI) flow of ≥1. Target lesion vessel length ≤25mm by visual estimation, target vessel diameter 2.5mm-4.0mm.
c. Each target lesion may be covered with one stent.
Long Lesion Subgroup:
- One de novo target lesion.
- Target lesion(s) must be located in a native coronary artery with a visually estimated stenosis ≥ 70% or ≥ 50% and < 100% with clinical evidence of myocardial ischemia, a thrombolysis in myocardial infarction (TIMI) flow of ≥1. Target lesion vessel length ≤34mm by visual estimation, target vessel diameter 3.0mm-4.0mm.
- 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:
(1)side branch ≥ 2.5 mm in diameter, or (2)side branch with diameter stenosis ≥ 50%, or (3)side branch requiring guide wire, or (4)side branch requiring dilatation. 4. Anatomy proximal to or within the lesion that may impair delivery of Firesorb :
- 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. 5. Lesion or vessel involves a myocardial bridge. 6. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
7. 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.
8. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
9. 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS
|
Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number and rate of Target Lesion Failure(TLF)
Time Frame: 1 year after index procedure
|
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.
|
1 year after index procedure
|
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
|
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
|
The number and rate of 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 at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold 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 residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold 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,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 ischemia-driven target lesion revascularization.
|
1 month,6 months,2 years,3 years,4 years and 5 years after index procedure
|
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
|
The number and rate of 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
|
The number and rate of 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
|
The number and rate of 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
|
The number and rate of Any Revascularization
Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
Ischemia-driven , Not ischemia-driven
|
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
|
The number and rate of Scaffold 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) Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable) 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUTURE-III
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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