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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Cardiovascular Systems Inc
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01930214
First received: August 21, 2013
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

The two objectives of the study are to assess the current standard of care treatment outcome in none/mild, moderate and severe calcified coronary lesions and to obtain financial data and procedure data to support reimbursement initiatives and health care economics analysis.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

Further study details as provided by Cardiovascular Systems Inc:

Primary Outcome Measures:
  • To assess the current standard of care treatment outcome in none/mild, moderate and severe calcified coronary lesions using a composite of MACE. [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    To assess the safety of the current standard of care treatment when used to facilitate stent deployment in de novo coronary lesions. This will be measured by a composite of MACE at 30-day and post index procedure. TVR will be determined by the Angiographic Core Laboratory.


Secondary Outcome Measures:
  • Characterization of health care costs associated with percutaneous coronary revascularization according to the level of lesion calcification. [ Time Frame: Procedure, one (1) year and three (3) year follow-up ] [ Designated as safety issue: No ]
    Heath care resource utilization, including hospital billing data (e.g., UB-04 forms, itemized bills) from the index hospitalization and any subsequent coronary revascularization procedures will be collected by the Health Economics Core Laboratory. These data will be used to characterize the health care costs associated with percutaneous coronary revascularization according to the level of lesion calcification and to support other secondary economic comparisons.

  • To assess the current standard of care treatment outcome in none/mild, moderate and severe calcified coronary lesions using a composite of MACE [ Time Frame: one (1) year post procedure ] [ Designated as safety issue: Yes ]
    To assess the safety of the current standard of care treatment when used to facilitate stent deployment in de novo coronary lesions. This will be measured by a composite of MACE rate at one (1) year post index procedure.

  • To assess the current standard of care treatment outcome in non/mild, moderate and severe calcified coronary lesions using procedural and lesion success. [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]
    To assess the current standard of care treatment capability of successfully facilitating stent deployment in de novo coronary lesions. 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, coronary lesion as determined by the Angiographic Core Laboratory. 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 index procedure without severe angiographic complications determined by the Angiographic Core Laboratory.


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
None/mild calcification
  • Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis, or
  • Presence of ≤180° of calcium at one (1) cross section.
Moderate Calcification
  • Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion, or
  • Presence of 181° to 269° of calcium at one (1) cross section.
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, or
  • Presence of ≥270° of calcium at one (1) cross section.

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 will 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. An interim analysis of standard of care treatment used will be performed after an arm has 40 subjects whom have completed the discharge visit. The duration of the study is expected to be approximately four (4) years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

18 years or older who are scheduled for percutaneous coronary revascularization involving stent.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930214

Contacts
Contact: Jennifer Olson 651-259-2825 j.olson@csi360.com
Contact: Janet Larson 651-202-4949 jlarson@csi360.com

  Show 37 Study Locations
Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
Principal Investigator: Samin K Sharma, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01930214     History of Changes
Other Study ID Numbers: CLN-0002-P
Study First Received: August 21, 2013
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2015