Clinical trial NCT01930214: Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
Official title: Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-08-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years or older who are scheduled for percutaneous coronary revascularization involving stent.

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

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be at least 18 years of age.
2. 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.
3. 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.
4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
5. The target vessel must be a native coronary artery with:

   1. A stenosis ≥ 70% and \< 100%, or
   2. A stenosis ≥ 50% \< 70% with evidence of clinical ischemia
6. The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm.
7. The lesion length must not exceed 40 mm.
8. The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow three (3) at baseline.

Exclusion Criteria:

1. Inability to understand the study or a history of non-compliance with medical advice.
2. Unwilling or unable to sign the MACE clinical study ICF.
3. History of any cognitive or mental health status that would interfere with study participation.
4. 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.).
5. Female subjects who are pregnant or planning to become pregnant within the study period.
6. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
7. Known sensitivity to contrast media, which cannot be adequately pre-medicated.
8. Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level \>2.5 mg/dl.
9. History of major cardiac intervention within 30-day, not including a PCI procedure for a staging purpose.
10. 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
11. History of a stroke or transient ischemic attack (TIA) within six (6) months
12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months.
13. History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
14. Concurrent medical condition with a life expectancy of \< 36 months.
15. History of immune deficiency.
16. Uncontrolled insulin dependent diabetes.
17. Evidence of active infections on the day of the index procedure.
18. Subject has planned cardiovascular intervention within 60 days post index procedure.
19. 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.
20. 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.
21. Target vessel has angiographically visible or suspected thrombus.
22. Target vessel appears to be/is excessively tortuous at baseline.
23. Target lesion is an ostial location (within 5mm of ostium) or an unprotected left main lesion.
24. Target lesion is a bifurcation (side branch ≥ 1.5mm).
25. Treatment of the target lesion with the CSI coronary Diamondback Orbital Atherectomy System (OAS).

Primary outcomes:
measure: MACE at 30 Days
timeFrame: 30 days post procedure
Secondary outcomes:
measure: MACE at One (1) Year
timeFrame: One (1) year post procedure
measure: Procedural Success
timeFrame: Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours
measure: Lesion Success
timeFrame: During the procedure
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Heart Institute
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of NW Florida
state: Florida
city: Augusta
country: United States
facility: Georgia Regents Research Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Regional
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Columbia
country: United States
facility: Boone Hospital
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai New York
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart & Vascular Specialists
state: North Carolina
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
city: Erie
country: United States
facility: University Pittsburg MC - Hamot
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Samin K Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.