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A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease (IRONMAN-II)

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Sponsored by
Biotyx Medical (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Patient must between 18 and 75 years old, male or non-pregnant female.
  2. Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, silent myocardial ischemia, or acute myocardial infarction>1 week) suitable for elective PCI.
  3. One or two de novo target lesions each located in a different epicardial vessel.

    1. If there is one target lesion, another 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 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 satisfy the angiographic eligibility criteria.
    3. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
  4. Lesion(s) must have a visually estimated length of ≤33mm, diameter between range of 2.5-4.0mm, and each lesion can be completely covered by a stent.
  5. Lesion(s) must have a visually estimated diameter stenosis of ≥70% (or ≥50% and have evidence of myocardial ischemia in this location) with a TIMI flow of ≥1
  6. Patient can understand the study purpose, voluntarily participate in the study, sign the informed consent, and willing to undergo protocol-required invasive angiographic follow-ups.

Exclusion Criteria:

  • General Exclusion Criteria

    1. Patient had an acute myocardial infarction (AMI) or CK and CK-MB have not returned to within normal limits after myocardial infarction within 7 days of the index procedure.
    2. Patient has implanted stent in the target vessel within 1 year of the index procedure, or is scheduled to undergo re-intervention in the future 6 months.
    3. Patient with a history of coronary artery bypass (coronary artery bypass grafting).
    4. Patient with contraindications on coronary artery bypass graft surgery.
    5. Patient with severe heart failure (NYHA class ≥III) or left ventricular ejection fraction<40% (by echocardiography or contrast left ventriculography).
    6. Patient with known renal insufficiency: serum creatinine > 2.0 mg/dl or 177 μmol/L, or/and patient on dialysis.
    7. Patient with known hepatic insufficiency: ALT, AST >3 times the upper limit of normal.
    8. Patient had an ischemic stroke within 6 months or transient ischemic neurological attack (TIA) within 3 months before the index procedure, or has tendency of hypercoagulation as per investigator judgement or laboratory test.
    9. Patient with bleeding diathesis, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy, and unable to undergoing antithrombotic therapy.
    10. Patient with known allergy to aspirin, clopidogrel, heparin, contrast agent, PDLLA, sirolimus and metal (iron, zinc etc).
    11. Patient with a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
    12. Patient with life expectancy <2 years.
    13. Patient is already participating in another drug or medical device clinical trial that has not yet reached its primary endpoint.
    14. Patient with poor compliance and cannot comply with the protocol requirement as per investigator judgement.
    15. Subject has received a heart transplant.
    16. Patient with unstable arrhythmia, such as high-risk ventricular premature beat and ventricular tachycardia.
    17. Patient requires chemotherapy for malignancy.
    18. Patient with known immunosuppressive or autoimmune disease, and is receiving or scheduled to receive immunosuppressant therapy.
    19. Patient is receiving or scheduled to receive chronic anticoagulation therapy such as aspirin and warfarin, etc.
    20. Patient is scheduled to receive a surgery that requires to stop antiplatelet drugs such as aspirin and clopidogrel.
    21. Patient has a platelet count <100x109/L or >700 x109/L, a white blood cell count of <3 x109/L during the screening period.
    22. Patient with diffuse peripheral vascular disease, and cannot use 6F catheter.
    23. Patient with prior valvular surgery.
  • Angiographic exclusion criteria

    1. Chronic total occlusion (TIMI flow of 0 before the index procedure).
    2. Target lesion is located in left main.
    3. Aorto-ostial lesion (within 3 mm of the ostium).
    4. Target lesion involving a bifurcation lesion with side branch ≥2.5 mm in diameter (the ostium of side branch has restenosis ≥40% or require balloon pre-dilatation).
    5. Visible thrombus in target vessels.
    6. Severe triple vessels lesions and all require revascularization.
    7. Severe calcified or distorted lesions which unable to predilate, not suitable for stent delivery and expansion, impair delivery including:

      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
    8. In-stent restenosis target lesion.
    9. Target lesion involves a myocardial bridge.
    10. The investigational stent would need to cross the previously implanted stent to reach the target lesion.
    11. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

      1. Residual diameter stenosis (DS%) is < 40% (per visual estimation), ≤ 20% is strongly recommended.
      2. TIMI flow of 3 (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

  • Fuwai Yunnan Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBS

XIENCE

Arm Description

Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System

Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

Outcomes

Primary Outcome Measures

In-segment Late lumen loss (LLL)

Secondary Outcome Measures

Powered Secondary Endpoint: Quantitative Flow Ratio (QFR)
Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT
Only for subjects in OCT subset
Rate of Device Success
Device Success is defined as: A visually estimated diameter stenosis of < 30% after implantation of the device and TIMI flow of III.
Rate of Lesion Success
Lesion Success is defined as: The attainment of visual residual stenosis < 30% and TIMI flow of III after any intervention in target lesion.
Rate of Clinical Success
Clinical Success is defined as: lesion success, AND there is no major adverse cardiac event in the hospitalization period.
Rate of Device-oriented Composite Endpoint (DoCE)
Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Rate of Patient-oriented Composite Endpoint (PoCE)
Including all-cause mortality, any myocardial infarction and any revascularization.
Rate of Death (Cardiac, Vascular and Non-cardiovascular)
Rate of Myocardial infarction (Attributable to target vessel (TV-MI),or Not attributable to target vessel (NTV-MI))
Rate of Target Lesion Revascularization (Ischemia driven, or not ischemia driven)
Rate of Target Vessel Revascularization (Ischemia driven, or not ischemia driven)
Rate of all coronary revascularization
Rate of Stent Thrombosis defined by ARC (definite and probable)
Stent thrombosis is defined by Academic Research Consortium (ARC) criteria as definite, probable, and possible. Stent thrombosis was categorized as acute, Subacute, late, very late.
Acute recoil
Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD)
Diameter stenosis (DS %) (In-device, in-segment, proximal 5mm and distal 5mm DS%)
Late Lumen Loss (LLL) (In-device, proximal 5mm and distal 5mm LLL)
Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR)
Thickness of neointima (struts level)
Minimal lumen area
Percentage of neointima-covered struts
Late incomplete strut apposition
Lumen area stenosis %
Healing score
Healing score = (presence of intra-scaffold structure * 4) + (presence of both malapposed and uncovered struts * 3) + (presence of uncovered struts alone * 2) + (presence of malapposition alone * 1).
Stent Absorption (%)
Late recoil area
Late recoil proportion

Full Information

First Posted
December 20, 2021
Last Updated
August 31, 2023
Sponsor
Biotyx Medical (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05206084
Brief Title
A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease
Acronym
IRONMAN-II
Official Title
A Prospective, Multi-Center, Single-Blinded, Randomized Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotyx Medical (Shenzhen) 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
A prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE).
Detailed Description
IRONMAN-II is a prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE). A total of 518 subjects with coronary artery lesion(s) are intended to participate in this study. Angiographic follow-up will be required at 2 years, and an OCT subset including 50 subjects will undergo OCT follow-up. Clinical follow-up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. The primary endpoint is late lumen loss at 2 years. The primary objective of this trial is to support the China pre-market approval of IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System. IRONMAN-II will evaluate the safety and efficacy of the IBS in treating patients with coronary artery disease. The primary endpoint is late lumen loss at 2 years. The powered secondary objective is to evaluate long-term vascular function and patency of the IBS treated segments compared to XIENCE treated segments. The powered secondary endpoints include Quantitative Flow Ratio (QFR) and cross-section level mean flow area measured by OCT for OCT subset at 2 years. Data from the primary endpoint and two powered secondary endpoints will evaluate the non-inferiority of the IBS as compared to XIENCE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
518 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBS
Arm Type
Experimental
Arm Description
Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System
Arm Title
XIENCE
Arm Type
Active Comparator
Arm Description
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Intervention Description
Subjects in this arm will be treated with IBS
Intervention Type
Device
Intervention Name(s)
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Intervention Description
Subjects in this arm will be treated with XIENCE
Primary Outcome Measure Information:
Title
In-segment Late lumen loss (LLL)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Powered Secondary Endpoint: Quantitative Flow Ratio (QFR)
Time Frame
2 years
Title
Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT
Description
Only for subjects in OCT subset
Time Frame
2 years
Title
Rate of Device Success
Description
Device Success is defined as: A visually estimated diameter stenosis of < 30% after implantation of the device and TIMI flow of III.
Time Frame
Immediately post-procedure
Title
Rate of Lesion Success
Description
Lesion Success is defined as: The attainment of visual residual stenosis < 30% and TIMI flow of III after any intervention in target lesion.
Time Frame
Immediately post-procedure
Title
Rate of Clinical Success
Description
Clinical Success is defined as: lesion success, AND there is no major adverse cardiac event in the hospitalization period.
Time Frame
≤ 7 days post the index procedure (In-hospital )
Title
Rate of Device-oriented Composite Endpoint (DoCE)
Description
Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Patient-oriented Composite Endpoint (PoCE)
Description
Including all-cause mortality, any myocardial infarction and any revascularization.
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Death (Cardiac, Vascular and Non-cardiovascular)
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Myocardial infarction (Attributable to target vessel (TV-MI),or Not attributable to target vessel (NTV-MI))
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Target Lesion Revascularization (Ischemia driven, or not ischemia driven)
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Target Vessel Revascularization (Ischemia driven, or not ischemia driven)
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of all coronary revascularization
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Rate of Stent Thrombosis defined by ARC (definite and probable)
Description
Stent thrombosis is defined by Academic Research Consortium (ARC) criteria as definite, probable, and possible. Stent thrombosis was categorized as acute, Subacute, late, very late.
Time Frame
1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Title
Acute recoil
Time Frame
Immediately post-procedure
Title
Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD)
Time Frame
at post-procedure, 2 years
Title
Diameter stenosis (DS %) (In-device, in-segment, proximal 5mm and distal 5mm DS%)
Time Frame
at post-procedure, 2 years
Title
Late Lumen Loss (LLL) (In-device, proximal 5mm and distal 5mm LLL)
Time Frame
2 years
Title
Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR)
Time Frame
2 years
Title
Thickness of neointima (struts level)
Time Frame
2 years
Title
Minimal lumen area
Time Frame
2 years
Title
Percentage of neointima-covered struts
Time Frame
2 years
Title
Late incomplete strut apposition
Time Frame
2 years
Title
Lumen area stenosis %
Time Frame
2 years
Title
Healing score
Description
Healing score = (presence of intra-scaffold structure * 4) + (presence of both malapposed and uncovered struts * 3) + (presence of uncovered struts alone * 2) + (presence of malapposition alone * 1).
Time Frame
2 years
Title
Stent Absorption (%)
Time Frame
2 years
Title
Late recoil area
Time Frame
2 years
Title
Late recoil proportion
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must between 18 and 75 years old, male or non-pregnant female. Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, silent myocardial ischemia, or acute myocardial infarction>1 week) suitable for elective PCI. One or two de novo target lesions each located in a different epicardial vessel. If there is one target lesion, another 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 result prior to randomization of the target lesion. If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch. Lesion(s) must have a visually estimated length of ≤33mm, diameter between range of 2.5-4.0mm, and each lesion can be completely covered by a stent. Lesion(s) must have a visually estimated diameter stenosis of ≥70% (or ≥50% and have evidence of myocardial ischemia in this location) with a TIMI flow of ≥1. Patient can understand the study purpose, voluntarily participate in the study, sign the informed consent, and willing to undergo protocol-required invasive angiographic follow-ups. Exclusion Criteria: General Exclusion Criteria Patient had an acute myocardial infarction (AMI) or CK and CK-MB have not returned to within normal limits after myocardial infarction within 7 days of the index procedure. Patient has implanted stent in the target vessel within 1 year of the index procedure, or is scheduled to undergo re-intervention in the future 6 months. Patient with a history of coronary artery bypass (coronary artery bypass grafting). Patient with contraindications on coronary artery bypass graft surgery. Patient with severe heart failure (NYHA class ≥III) or left ventricular ejection fraction<40% (by echocardiography or contrast left ventriculography). Patient with known renal insufficiency: serum creatinine > 2.0 mg/dl or 177 μmol/L, or/and patient on dialysis. Patient with known hepatic insufficiency: ALT, AST >3 times the upper limit of normal. Patient had an ischemic stroke within 6 months or transient ischemic neurological attack (TIA) within 3 months before the index procedure, or has tendency of hypercoagulation as per investigator judgement or laboratory test. Patient with bleeding diathesis, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy, and unable to undergoing antithrombotic therapy. Patient with known allergy to aspirin, clopidogrel, heparin, contrast agent, PDLLA, sirolimus and metal (iron, zinc etc). Patient with a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc. Patient with life expectancy <2 years. Patient is already participating in another drug or medical device clinical trial that has not yet reached its primary endpoint. Patient with poor compliance and cannot comply with the protocol requirement as per investigator judgement. Subject has received a heart transplant. Patient with unstable arrhythmia, such as high-risk ventricular premature beat and ventricular tachycardia. Patient requires chemotherapy for malignancy. Patient with known immunosuppressive or autoimmune disease, and is receiving or scheduled to receive immunosuppressant therapy. Patient is receiving or scheduled to receive chronic anticoagulation therapy such as aspirin and warfarin, etc. Patient is scheduled to receive a surgery that requires to stop antiplatelet drugs such as heparin and clopidogrel within 6 months after the index procedure. Patient has a platelet count <100x10^9/L or >700 x10^9/L, a white blood cell count of <3 x10^9/L during the screening period. Patient with diffuse peripheral vascular disease, and cannot use 6F catheter. Patient with prior valvular surgery. Angiographic exclusion criteria Chronic total occlusion (TIMI flow of 0 before the index procedure). Target lesion is located in left main. Aorto-ostial lesion (within 3 mm of the ostium). Target lesion involving a bifurcation lesion with side branch ≥2.5 mm in diameter (the ostium of side branch has restenosis ≥40% or require balloon pre-dilatation). Visible thrombus in target vessels. Severe triple vessels lesions and all require revascularization. Severe calcified or distorted lesions which unable to predilate, not suitable for stent delivery and expansion, impair delivery including: 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 In-stent restenosis target lesion. Target lesion involves a myocardial bridge. The investigational stent would need to cross the previously implanted stent to reach the target lesion. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes: Residual diameter stenosis (DS%) is < 40% (per visual estimation), ≤ 20% is strongly recommended. TIMI flow of 3 (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.
Facility Information:
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Kunming
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease

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