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A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II (FUTURE-II)

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ClinicalTrials.gov Identifier: NCT02890160
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

Brief Summary:
The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Firesorb Device: XIENCE Not Applicable

Detailed Description:
This study is a prospective, multicenter, single-blind, randomized controlled trial in patients with coronary artery disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The goal is to evaluate the safety and effectiveness of Firesorb to support the approval of the Chinese Food and Drug Administration (CFDA) for this product. The Abbott's XIENCE Everolimus-eluting Coronary Stent System is selected as the control device. 610 subjects will be recruited and divided into queue 1 (n=430) and queue 2 (n=180). All subjects in two queues will be 1:1 randomly assigned to experimental group and control group. All subjects will undergo clinical follow-up at 1-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-index procedure. Subjects in queue 1 will undergo angiographic follow-up at 1-year post-index procedure; of which 3-5 centers will be specified as a subgroup to complete OCT follow-up (n=80, 40 each in test and control group). Subjects in queue 2 will undergo angiographic follow-up at 2-year post-index procedure; of which 40 subjects will complete OCT follow-up (20 each in test and control group).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-II
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Firesorb
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)
Device: Firesorb
Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Active Comparator: XIENCE
Implantation of the XIENCE Everolimus Eluting Coronary Stent System
Device: XIENCE
Everolimus Eluting Coronary Stent System




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The percentage of intima coverage-strut (OCT subgroup) [ Time Frame: 1 year after index procedure ]
    The main secondary endpoint

  2. Vasomotion (Queue 2) [ Time Frame: 2 year after index procedure ]
    The changes in average lumen diameter before and after intracoronary nitroglycerin

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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)

  9. 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)

  10. 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)

  11. Any Revascularization [ Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure ]
  12. 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)

  13. 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 ).

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Acute Stent Recoil [ Time Frame: Immediately after index procedure ]
  19. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. 18-75 years of age, males or non-pregnant females;
  2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
  3. Patients with indications for coronary artery bypass graft surgery;
  4. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:

    1. 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.
    2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
    3. 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.
  2. 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.
  3. Each target lesion may be covered with one stent.

General Exclusion Criteria:

  1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
  2. Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
  3. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <40% (ultrasound or left ventricular angiography);
  4. Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
  5. 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;
  6. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  7. The patient's life expectancy is less than 12 months;
  8. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  9. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  10. Heart transplantation patients;
  11. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
  12. Cancer need chemotherapy;
  13. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
  14. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
  15. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
  16. 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);
  17. Peripheral vascular disease, 6F catheter is not available.

Angiographic Exclusion Criteria:

  1. left main coronary artery disease;
  2. severe triple vessel lesion and required revascularization.

The following exclusion criteria apply to the target lesion(s) or target vessel(s):

  1. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
  2. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
  3. 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 or XIENCE stent:

    1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
    3. 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:

    1. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
    2. TIMI Grade-3 flow (per visual estimation).
    3. No angiographic complications (e.g. distal embolization, side branch closure).
    4. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
    5. No chest pain lasting > 5 minutes.
    6. No ST depression or elevation lasting > 5 minutes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890160


Contacts
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Contact: Bo Xu, MBBS 010-88322562 bxu@citmd.com
Contact: Runlin Gao, MD

Locations
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China, Beijing
Fu Wai Hospital Recruiting
Peking, Beijing, China, 100037
Contact: Bo Xu, MBBS    +86-10-88322562    bxu@citmd.com   
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
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Principal Investigator: Runlin Gao, MD Fu Wai Hospital & National Center for Cardiovascular Diseases in China
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Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02890160    
Other Study ID Numbers: MicroPort_Firesorb_RCT
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
Bioresorbable Vascular Scaffold
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases