Coronary Artery DiseaseMACENCT01930214
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 34 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 350 participants
- Where
- 34 sitesUnited States
- Study dates
- 26 Sep 2013to 1 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years or older who are scheduled for percutaneous coronary revascularization involving stent.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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:
- 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).
- Treatment of the target lesion with the CSI coronary Diamondback Orbital Atherectomy System (OAS).
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Georgia Regents Research Institute
Augusta, Georgia, 30912
John Hopkins
Baltimore, Maryland, 21287
McLaren Bay Regional
Bay City, Michigan, 48708
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637
Clearwater Cardiovascular & Interventional Consultants
Clearwater, Florida, 33756
Boone Hospital
Columbia, Missouri, 65201
OhioHealth Research Institute
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
University Pittsburg MC - Hamot
Erie, Pennsylvania, 16507
Glendale Adventist Medical Center
Glendale, California, 91206
East Carolina University
Greenville, North Carolina, 27858
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist Research Institute
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Saint Luke's
Kansas City, Missouri, 64111
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
University of Tennessee
Memphis, Tennessee, 38116
Mount Sinai Medical Center Heart Institute
Miami Beach, Florida, 33140
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
Mission Research Institute
New Braunfels, Texas, 78130
Mount Sinai New York
New York, New York, 10029
Cardiovascular Institute of NW Florida
Panama City, Florida, 32401
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
North Carolina Heart & Vascular Specialists
Raleigh, North Carolina, 27607
Beaumont Hospital
Royal Oak, Michigan, 48073
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Baystate Medical Center
Springfield, Massachusetts, 00119
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. John Health System
Tulsa, Oklahoma, 74104
Providence Health Center
Waco, Texas, 76712
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
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
Read the detailed description
This prospective, non-randomized, multi-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. This study may treat up to approximately 500 subjects at up to 50 active sites in the U.S. Subjects may be followed up to three (3) years. Subjects will be stratified into one (1) of three (3) arms based on the degree of calcification in the coronary lesion as defined by this protocol. The duration of the study is expected to be approximately four (4) years.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| None/mild calcification | Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Receives: Device: Percutaneous Coronary Intervention | |
| Moderate Calcification | Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Receives: Device: Percutaneous Coronary Intervention | |
| 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. Receives: Device: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post procedure
Secondary outcomes (3)
MACE at One (1) Year
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 1 year.
1-year 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
Measured: One (1) year post procedure
Procedural Success
Procedural success is defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE.
Measured: Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours
Lesion Success
Lesion success is defined as success in facilitating stent delivery with a post-procedural result of <50% residual stenosis for a given lesion treated during the procedure without severe angiographic complications.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study start26 Sep 2013
- Primary completion7 Nov 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samin K Sharma, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930214
- Sponsor's protocol ID
- CLN-0002-P
- Acronym
- MACE
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2013
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30681262
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
- ClinicalTrials.gov ID
- NCT01930214
- Acronym / sponsor ID
- MACE / CLN-0002-P
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2013 (actual)
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Posted 24 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This prospective, non-randomized, multi-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. This study may treat up to approximately 500 subjects at up to 50 active sites in the U.S. Subjects may be followed up to three (3) years. Subjects will be stratified into one (1) of three (3) arms based on the degree of calcification in the coronary lesion as defined by this protocol. The duration of the study is expected to be approximately four (4) years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| None/mild calcification | – | Device: Percutaneous Coronary InterventionPresence of readily apparent radiopacities within the vascular wall at the site of the stenosis. |
| Moderate Calcification | – | Device: Percutaneous Coronary InterventionPresence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. |
| Severe calcification | – | Device: Percutaneous Coronary InterventionPresence 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older who are scheduled for percutaneous coronary revascularization involving stent.
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionAny 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). | Device | Moderate Calcification, None/mild calcification, Severe calcification |
Primary outcome
MACE at 30 Days
Time frame: 30 days post procedure
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
3 secondary outcomes
MACE at One (1) Year
Time frame: One (1) year post procedure
Procedural Success
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours
Lesion Success
Time frame: During the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30681262Sharma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samin K Sharma, MD principal investigator
Icahn School of Medicine at Mount Sinai
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE at 30 Days (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.