Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
MACE
1 other identifier
observational
350
1 country
34
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedStudy Start
First participant enrolled
September 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
April 24, 2019
CompletedJuly 18, 2023
July 1, 2023
3.1 years
August 21, 2013
December 17, 2018
July 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
MACE at 30 Days
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 30 days. 30-day MACE is composed of: * Cardiac death * Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave * Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
30 days post procedure
Secondary Outcomes (3)
MACE at One (1) Year
One (1) year post procedure
Procedural Success
Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours
Lesion Success
During the procedure
Study Arms (3)
None/mild calcification
Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.
Moderate Calcification
Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.
Severe calcification
Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.
Interventions
Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Eligibility Criteria
18 years or older who are scheduled for percutaneous coronary revascularization involving stent.
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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
Clearwater Cardiovascular & Interventional Consultants
Clearwater, Florida, 33756, United States
Mount Sinai Medical Center Heart Institute
Miami Beach, Florida, 33140, United States
Cardiovascular Institute of NW Florida
Panama City, Florida, 32401, United States
Georgia Regents Research Institute
Augusta, Georgia, 30912, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701, United States
Indiana University
Indianapolis, Indiana, 46202, United States
John Hopkins
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 00119, United States
McLaren Bay Regional
Bay City, Michigan, 48708, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Boone Hospital
Columbia, Missouri, 65201, United States
Saint Luke's
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Mount Sinai New York
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27858, United States
North Carolina Heart & Vascular Specialists
Raleigh, North Carolina, 27607, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
St. John Health System
Tulsa, Oklahoma, 74104, United States
University Pittsburg MC - Hamot
Erie, Pennsylvania, 16507, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Tennessee
Memphis, Tennessee, 38116, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Mission Research Institute
New Braunfels, Texas, 78130, United States
Providence Health Center
Waco, Texas, 76712, United States
Related Publications (1)
Sharma SK, Bolduan RW, Patel MR, Martinsen BJ, Azemi T, Giugliano G, Resar JR, Mehran R, Cohen DJ, Popma JJ, Waksman R. Impact of calcification on percutaneous coronary intervention: MACE-Trial 1-year results. Catheter Cardiovasc Interv. 2019 Aug 1;94(2):187-194. doi: 10.1002/ccd.28099. Epub 2019 Jan 25.
PMID: 30681262RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Cardiovascular Systems Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Samin K Sharma, MD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2013
First Posted
August 28, 2013
Study Start
September 26, 2013
Primary Completion
November 7, 2016
Study Completion
June 1, 2017
Last Updated
July 18, 2023
Results First Posted
April 24, 2019
Record last verified: 2023-07