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

Coronary Artery Disease Clinical Trial

— MACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930214
• Other study ID #: CLN-0002-P
• Status: Completed
• Start date: September 26, 2013
• Est. completion date: June 1, 2017

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 1, 2017
• Est. primary completion date: November 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Percutaneous Coronary Intervention
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).

Locations

Country	Name	City	State
United States	Georgia Regents Research Institute	Augusta	Georgia
United States	John Hopkins	Baltimore	Maryland
United States	McLaren Bay Regional	Bay City	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Clearwater Cardiovascular & Interventional Consultants	Clearwater	Florida
United States	Boone Hospital	Columbia	Missouri
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University Pittsburg MC - Hamot	Erie	Pennsylvania
United States	Glendale Adventist Medical Center	Glendale	California
United States	East Carolina University	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Research Institute	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Saint Luke's	Kansas City	Missouri
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	University of Tennessee	Memphis	Tennessee
United States	Mount Sinai Medical Center Heart Institute	Miami Beach	Florida
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	Mission Research Institute	New Braunfels	Texas
United States	Mount Sinai New York	New York	New York
United States	Cardiovascular Institute of NW Florida	Panama City	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	North Carolina Heart & Vascular Specialists	Raleigh	North Carolina
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	St. John Health System	Tulsa	Oklahoma
United States	Providence Health Center	Waco	Texas
United States	MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	One (1) year post procedure
Secondary	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.	Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours
Secondary	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.	During the procedure