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ABILITY Diabetes Global (ABILITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236609
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Concept Medical Inc.

Brief Summary:
To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Condition or disease Intervention/treatment Phase
Diabetes Coronary Artery Disease Acute Coronary Syndrome Device: Abluminus DES+ Sirolimus Eluting Stent System (SES) Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family) Not Applicable

Detailed Description:
This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Target lesions should be treated in accordance with the randomization schedule after meeting the clinical and angiographic inclusion and exclusion criteria following the instruction for use of the study stent.

Additional lesions (other vessels) may be staged up to 45 days post-index procedure but must be treated with the same stent.

Dual antiplatelet therapy must be prescribed in alignment with the Instructions for Use of the DES and the guidelines

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global - ABILITY Diabetes Global
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Abluminus DES+ sirolimus- eluting stents (SES)
Enrolled patients will undergo angioplasty with Abluminus DES+ sirolimus- eluting stents (SES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the Abluminus DES+ sirolimus- eluting stents (SES).
Device: Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical

Active Comparator: XIENCE Everolimus-Eluting Stents (EES)
Enrolled patients will undergo angioplasty with XIENCE Everolimus-Eluting Stents (EES) and will be followed for two years. The DES procedure will be conducted in accordance with the CE mark instructions for use for the XIENCE Everolimus-Eluting Stents (EES).
Device: XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA




Primary Outcome Measures :
  1. Rate of Ischemia-driven TLR [ Time Frame: 1 year FU ]
    powered for non-inferiority and sequentially superiority

  2. Rate of Target lesion failure TLF [ Time Frame: 1 year FU, powered for non-inferiority ]
    composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR])


Secondary Outcome Measures :
  1. Safety composite endpoint [ Time Frame: 1 year (non-inferiority) ]
    Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)

  2. co-primary TLR endpoint [ Time Frame: 2 Year FU ]
    In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2-year FU will be evaluated (efficacy endpoint - superiority)

  3. Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) [ Time Frame: 1 year FU ]

    Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected:

    1. Death caused by acute MI
    2. Death caused by sudden cardiac, including unwitnessed, death
    3. Death resulting from heart failure
    4. Death caused by stroke
    5. Death caused by cardiovascular procedures
    6. Death resulting from cardiovascular hemorrhage
    7. Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.

      • Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.
      • Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.

  4. Bleeding [ Time Frame: 2 year ]
    Bleeding BARC 2 or greater


Other Outcome Measures:
  1. Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) [ Time Frame: 2 year FU ]

    Cardiovascular death is defined as death resulting from cardiovascular causes. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.

    Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.


  2. Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) [ Time Frame: 2 year ]

    Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected:

    1. Death caused by acute MI
    2. Death caused by sudden cardiac, including unwitnessed, death
    3. Death resulting from heart failure
    4. Death caused by stroke
    5. Death caused by cardiovascular procedures
    6. Death resulting from cardiovascular hemorrhage
    7. Death resulting from other cardiovascular cause. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.

      • Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.
      • Coronary artery bypass grafting (CABG) related MI is termed type 5 MI.

  3. All-cause mortality [ Time Frame: up to 2 years from procedure ]
    all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.

  4. Stroke [ Time Frame: up to 2 years from procedure ]
    according to Neuro-ARC stroke/TIA criteria

  5. Stent thrombosis [ Time Frame: 2 year ]
    defined for grade and timing according to the Academic Research Consortium2

  6. Technical success [ Time Frame: 2 year ]
    Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade TIMI flow 2 or 3 and a <30% residual stenosis. (As applies to chronic total occlusion - CTO - lesions)

  7. Clinical procedural success [ Time Frame: 2 year ]

    In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure (and without flow limiting arterial dissection and hemodynamically significant translesional pressure gradient) without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by use of adjunctive devices (e.g., percutaneous mechanical thrombectomy, directional or rotational atherectomy, laser, chronic total occlusion crossing device).

    Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory.


  8. Occurrence of ischemia-driven TLR [ Time Frame: 2 year FU ]
    Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.

  9. Target vessel revascularization (TVR) [ Time Frame: up to 2 years ]
    TLR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.



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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical Inclusion Criteria

  1. Patient understands the trial requirements and the treatment procedures and provides written informed consent;
  2. Age ≥ 18 years of age (> 19 years of age for South Korea and ≥ 21 years of age for Singapore);
  3. Diabetic patient: either:

    1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
    2. Newly diagnosed diabetes: either:

    i. Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for ≥8 hours1 or ii. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level ≥ 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin)

  4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed >12 months before index procedure;
  6. Patient is willing and able to comply with all protocol-required follow-up evaluations.

    Angiographic Inclusion Criteria (visual estimate)

  7. Presence of ≥1 de novo coronary artery stenosis >50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and
  8. No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.

Exclusion Criteria:

Clinical Exclusion Criteria

  1. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
  2. Patient in cardiogenic shock;
  3. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, platinum, chromium, sirolimus, everolimus, radiographic contrast material) that cannot be adequately pre-medicated;
  4. Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical period;
  5. Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)
  6. Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception*;
  7. Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months;
  8. Acute or chronic renal dysfunction (creatinine >3.0 mg/dl);
  9. Currently participating in another investigational drug or device study.

    Angiographic Exclusion Criteria

  10. In-stent restenotic lesions;
  11. Lesions involving venous or arterial bypass grafts.

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): NCT04236609


Contacts
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Contact: Prakash Sojitra, Phd +91 9099916094 prakash@conceptmedical.com
Contact: Farhana Siddique +91 9099916091 farhana@conceptmedicals.com

Sponsors and Collaborators
Concept Medical Inc.
Investigators
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Study Chair: Roxana Mehran Mount Sinai Heart

Publications of Results:
Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9

Other Publications:
International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2
Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003

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Responsible Party: Concept Medical Inc.
ClinicalTrials.gov Identifier: NCT04236609    
Other Study ID Numbers: COMED.CT.DES.001
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents