Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

Completed

Conditions studied: Coronary Artery Disease

In brief

The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: * A composite of MACE at 30-day and one (1) year post procedure, and * Procedural and lesion success

Key facts

Study ID

NCT01930214

Run by

Abbott Medical Devices

People needed

350

Starts

2013-09-26

Expected to finish

2017-06-01

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be at least 18 years of age.
• Subjects must be scheduled for percutaneous coronary revascularization involving stent deployment in de novo coronary lesions. Percutaneous coronary revascularization is defined as treatment with commercially available devices that may include but not limited to balloon angioplasty, cutting balloon, rotablation, etc. followed by the stent placement.
• Subjects CK-MB must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to procedure. If CK-MB results are not yet available prior to initiating procedure, subjects Troponin I or Troponin T must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to the procedure.
• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
• The target vessel must be a native coronary artery with:
• A stenosis ≥ 70% and < 100%, or
• A stenosis ≥ 50% < 70% with evidence of clinical ischemia
• The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm.
• The lesion length must not exceed 40 mm.
• The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow three (3) at baseline.

You may not qualify if…

• Inability to understand the study or a history of non-compliance with medical advice.
• Unwilling or unable to sign the MACE clinical study ICF.
• History of any cognitive or mental health status that would interfere with study participation.
• Currently enrolled in any other pre-approval investigational study. This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
• Known sensitivity to contrast media, which cannot be adequately pre-medicated.
• Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level >2.5 mg/dl.
• History of major cardiac intervention within 30-day, not including a PCI procedure for a staging purpose.
• Evidence of heart failure by one of the following:
• i. Left Ventricular Ejection Fraction (LVEF) ≤ 25% ii. New York Heart Association (NYHA) class III or IV iii. Clinical symptoms
• History of a stroke or transient ischemic attack (TIA) within six (6) months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months.
• History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
• Concurrent medical condition with a life expectancy of < 36 months.
• History of immune deficiency.
• Uncontrolled insulin dependent diabetes.
• Evidence of active infections on the day of the index procedure.
• Subject has planned cardiovascular intervention within 60 days post index procedure.
• Subject with angiographically confirmed evidence of more than two (2) lesions within one (1) vessel or more than one (1) vessel requiring intervention, unless the treatment is staged. See Section 10.1 for more details.
• Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or Left Internal Mammary Artery/ Right Internal Mammary Artery (LIMA/RIMA) bypass.
• Target vessel has angiographically visible or suspected thrombus.
• Target vessel appears to be/is excessively tortuous at baseline.
• Target lesion is an ostial location (within 5mm of ostium) or an unprotected left main lesion.
• Target lesion is a bifurcation (side branch ≥ 1.5mm).

Where it is running

• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MedStar Washington Hospital — Washington D.C., District of Columbia, United States
• Clearwater Cardiovascular & Interventional Consultants — Clearwater, Florida, United States
• Mount Sinai Medical Center Heart Institute — Miami Beach, Florida, United States
• Cardiovascular Institute of NW Florida — Panama City, Florida, United States
• Georgia Regents Research Institute — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• John Hopkins — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• McLaren Bay Regional — Bay City, Michigan, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• Boone Hospital — Columbia, Missouri, United States
• Saint Luke's — Kansas City, Missouri, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Jersey Shore Medical Center — Neptune City, New Jersey, United States
• Mount Sinai New York — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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