A clinical evaluation to compare the safety, efficacy and performance of ABSORB everolimus eluting bioresorbable vascular scaffold against XIENCE PRIME everolimus eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions

Completed

• Conditions: angina pectoris; ischemic heart disease; 10011082

• Registration Number: NL-OMON39935
• Lead Sponsor: Abbott Vascular International BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

• Subject must be at least 18 years of age and less than 85 years of age.
• Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnairebased studies, or other studies that are non-invasive and do not require medication are allowed.
• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB scaffold and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to ESC Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight.;Angiographic Inclusion Criteria
• One or two de novo native lesions each located in a different epicardial vessel.
• If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and RCA and any of its branches).
• Target lesion(s) must have a visually estimated diameter stenosis of >=50% and <100% with a TIMI flow of >= 1.
• Lesion(s) must be located in a native coronary artery with Dmax by online QCA of >= 2.25 mm and <= 3.3 mm.
• Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of <= 48 mm.
• Percutaneous interventions for lesions in a non-target vessel are allowed if done >=30 days prior to or if planned to be done 2 years after the index procedure.
• Percutaneous intervention for lesions in the target vessel are allowed if done >6 months prior to or if planned to be done 2 years after the index procedure.

Exclusion Criteria

General Exclusion Criteria
• Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin,
antiplatelet medications specified for use in the study (clopidogrel and prasugrel and
ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium,
nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
• Subject has a known diagnosis of acute myocardial infarction (AMI) at any time
preceding the index procedure and relevant cardiac enzymes (according to local standard
hospital practice) have not returned within normal limits at the time of procedure.
• Evidence of ongoing acute myocardial infarction in ECG prior to procedure
• Subject has current unstable arrhythmias.
• Left ventricular ejection fraction (LVEF) < 30%.
• Subject has received a heart transplant or any other organ transplant or is on a waiting list
for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days
prior to or after the procedure.
• Subject is receiving immunosuppressant therapy and/or has known immunosuppressive
or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus
erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive
medication, etc.).
• Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted
according to local hospital standard procedures.
• Elective surgery is planned within 2 years after the procedure that will require
discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine.
• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of
<3,000 cells/mm3, or documented or suspected liver disease (including laboratory
evidence of hepatitis)
• Known renal insufficiency (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5
mg/dL, or subject on dialysis).
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological
attack (TIA) within the past 6 months.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years
following index procedure. (Female subjects of child-bearing potential must have a
negative pregnancy test done within 28 days prior to the index procedure and
contraception must be used during participation in this trial)
• Other medical illness (e.g., cancer or congestive heart failure) or known history of
substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause
non-compliance with the protocol or confound the data interpretation or is associated
with a limited life expectancy.
• Subject is already participating in another clinical investigation that has not yet reached
its primary endpoint.
• Subject is belonging to a vulnerable population (per investigator*s judgment, e.g.,
subordinate hospital staff or sponsor staff) or subject unable to read or write.;Angiographic Exclusion Criteria
• Target lesion which prevents adequate (residual stenosis at target lesion(s) is <= 40% by
visual assessment) coronary pre-dilatation.
• Target lesion in left main trunk.
• Aorto-ostial target lesion (within 3 mm of the aorta junction).
• Target les

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Vasomotion assessed by change in Mean Lumen Diameter between pre- and<br /><br>post-nitrate at 3 years (superiority)<br /><br>• Minimum Lumen Diameter (MLD) at 3 years post nitrate minus MLD post procedure<br /><br>post nitrate (non-inferiority, reflex to superiority)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-) Acute success, including stent success (lesion analysis) and procedural<br /><br>success (subject analysis)<br /><br>-) Clinical endpoints (after 30 days, 180 days, 1-5 years follow up),<br /><br>including: death (cardiac, vascular, not cardiovascular), myocardial infarction<br /><br>(MI: QMI and NQMI) , revascularization<br /><br>-) Composite endpoints, including: Death / MI all, Cardiac death<br /><br>-) Scaffold-/stenttrombose, incl timing (acute, subacute, late and very late)<br /><br>-) Quality of Life (QoL) </p><br>