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Trial for MicroPort's Firesorb BVS: FUTURE-III (FUTURE-III)

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Firesorb
Sponsored by
Shanghai MicroPort Medical (Group) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bioresorbable Vascular Scaffold

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Angiographic Inclusion Criteria:

  1. General Specification Subgroup:

    1. 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.

  2. Long Lesion Subgroup:

    1. One de novo target lesion.
    2. 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.
    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;
  3. Patients with planned intervention again within six months;
  4. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <40% (ultrasound or left ventricular angiography);
  5. Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
  6. 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;
  7. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  8. The patient's life expectancy is less than 12 months;
  9. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  10. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  11. Heart transplantation patients;
  12. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
  13. Cancer need chemotherapy;
  14. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
  15. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
  16. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
  17. 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);
  18. 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 :

  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.

Sites / Locations

  • Fu Wai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Single Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS

Outcomes

Primary Outcome Measures

The number and rate of Target Lesion Failure(TLF)
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.

Secondary Outcome Measures

The number and rate of Acute Success-Device Success
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.
Acute Success-Procedural Success
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.
Device-oriented composite endpoints (Target Lesion Failure)
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.
Patient-oriented clinical composite endpoint (PoCE)
Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.
Death (Cardiac, Vascular, Non-cardiovascular)
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.
The number and rate of Myocardial Infarction (MI)
Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI)
The number and rate of Target Vessel Revascularization (TVR)
Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR)
The number and rate of Target Lesion Revascularization (TLR)
Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR)
The number and rate of Any Revascularization
Ischemia-driven , Not ischemia-driven
The number and rate of Scaffold Thrombosis (per ARC definition)
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)

Full Information

First Posted
September 4, 2018
Last Updated
September 10, 2018
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03660202
Brief Title
Trial for MicroPort's Firesorb BVS: FUTURE-III
Acronym
FUTURE-III
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The FUTURE-III 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.
Detailed Description
This study is a prospective, multicenter, single-arm 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.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. A total of 1200 subjects will be recruited, including 96 with long lesion (the scaffold to be used with a length of 33mm or 38mm) and 215 in the experimantal group of FUTURE-II clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Bioresorbable Vascular Scaffold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Single Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS
Intervention Type
Device
Intervention Name(s)
Firesorb
Intervention Description
Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)
Primary Outcome Measure Information:
Title
The number and rate of Target Lesion Failure(TLF)
Description
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.
Time Frame
1 year after index procedure
Secondary Outcome Measure Information:
Title
The number and rate of Acute Success-Device Success
Description
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.
Time Frame
From the start of index procedure to end of index procedure
Title
Acute Success-Procedural Success
Description
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.
Time Frame
At time of procedure up to 7 days in hospital
Title
Device-oriented composite endpoints (Target Lesion Failure)
Description
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.
Time Frame
1 month,6 months,2 years,3 years,4 years and 5 years after index procedure
Title
Patient-oriented clinical composite endpoint (PoCE)
Description
Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
Death (Cardiac, Vascular, Non-cardiovascular)
Description
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.
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
The number and rate of Myocardial Infarction (MI)
Description
Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI)
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
The number and rate of Target Vessel Revascularization (TVR)
Description
Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR)
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
The number and rate of Target Lesion Revascularization (TLR)
Description
Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR)
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
The number and rate of Any Revascularization
Description
Ischemia-driven , Not ischemia-driven
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Title
The number and rate of Scaffold Thrombosis (per ARC definition)
Description
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)
Time Frame
1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Xu, MBBS
Phone
010-88322562
Email
bxu@citmd.com
Facility Information:
Facility Name
Fu Wai Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

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Trial for MicroPort's Firesorb BVS: FUTURE-III

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