Trial record 2 of 159 for:    daniel lee | Open Studies

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 August 2013 by Cardiovascular Systems Inc
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01930214
First received: August 21, 2013
Last updated: January 8, 2014
Last verified: August 2013
  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
Calcification in Coronary Lesions

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 post index procedure. TVR will be determined by the Angiographic Core Laboratory.

  • To Assess the current standard of care traetment 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/mil, 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.


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.


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 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 as demonstrated by either:

    i. Positive stress test, or ii. Fractional Flow Reserve (FFR) value ≤ 0.8, or iii. IVUS minimum lumen area (MLA) ≤ 4.0 mm2

  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 within the last 6 months by either:

    i. Left Ventricualr Ejection Fraction (LVEF) ≤ 25%, or ii. New York Heart Association (NYHA) class III or IV, or 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.
  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: Jessica Kleine 651-259-2840 jkleine@csi360.com
Contact: Katherine Kumar 651-259-1621 kkumar@csi360.com

Locations
United States, Arkansas
Arkansas Heart Hospital Not yet recruiting
Little Rock, Arkansas, United States, 72211
Contact: David Mego, MD    501-664-5860    david.mego@arheart.com   
Contact: Brandy Griffin    501-978-3702    brandy.griffin@arheart.com   
Principal Investigator: David Mego, MD         
United States, California
Glendale Adventist Medical Center Recruiting
Glendale, California, United States, 91206
Contact: Harry Balian, MD    818-243-9600    Md4hart@yahoo.com   
Contact: Lily Villalobos    818-409-8464    lily.villalobos@ah.org   
Principal Investigator: Harry Balian, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Talhat Azemi, MD    860-545-2975    tazemi@harthosp.org   
Contact: Deborah Katten    860-545-1537    Deborah.Katten@hhchealth.org   
Principal Investigator: Talhat Azemi, MD         
United States, Florida
Lakeland Regional Medical Center Not yet recruiting
Lakeland, Florida, United States, 33805
Contact: Douglas Ebersole, MD    863-904-2482    DEbersole@watsonclinic.com   
Contact: Noreen McGowan    863-904-2482    nmcgowan@watsonclinic.com   
Principal Investigator: Douglas Ebersole, MD         
Mount Sinai Medical Center Heart Institute Recruiting
Miami Beach, Florida, United States, 33140
Contact: Nirat Beohar, MD    305-674-2754    Nirat.beohar@msmc.com   
Contact: Ana Mon    305-674-2169    Ana.mon@msmc.com   
Principal Investigator: Nirat Beohar, MD         
United States, Maryland
John Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Jon Resar, MD    410-614-1132    jresar@jhmi.edu   
Contact: Audrey Dudek    410-955-6839    adudek1@jhmi.edu   
Principal Investigator: Jon Resar, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Maryland, United States, 02215
Contact: Donald Cutlip, MD    617-667-8800    dcutlip@bidmc.harvard.edu   
Contact: Jenifer Kaufman    617-632-8956    jmkaufma@bidmc.harvard.edu   
Principal Investigator: Donald Cutlip, MD         
United States, Michigan
McLaren Bay Regional Not yet recruiting
Bay City, Michigan, United States, 48708
Contact: Daniel Lee, MD    989-894-3278    Daniel.lee1965@gmail.com   
Contact: Colette Quart    989-894-3290    Colette.Quart@mclaren.org   
Principal Investigator: Daniel Lee, MD         
United States, Missouri
Boone Hospital Recruiting
Columbia, Missouri, United States, 65201
Contact: Sanjeev Ravipudi, MD    573-256-7700    sravipudi@moheartcenter.com   
Contact: Kelly Melegrito    573-256-3046    kellym@moheartcenter.com   
Principal Investigator: Sanjeev Ravipudi, MD         
Saint Luke's Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: Charles Barth, MD    816-931-1883    cbarth@saint-lukes.org   
Contact: Lindsey Seifert    816-932-9862    lseifert@saint-lukes.org   
Principal Investigator: Charles Barth, MD         
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: John Lasala, MD    314-362-3729    jlasala@dom.wustl.edu   
Contact: Holly Wiesehan    314-362-1986    hwieseha@dom.wustl.edu   
Principal Investigator: John Lasala, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Virender Sethi, MD    551-996-2744    vsethi@hackensackUMC.org   
Contact: Jana Tancredi    551-996-2353    jtancredi@hackensackUMC.org   
Principal Investigator: Virender Sethi, MD         
Jersey Shore Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Ziad Abbud, MD    732-663-1123    ziadabbud@optonline.net   
Contact: Linda Murphy    732776-4796    lMurphy@meridianhealth.com   
Principal Investigator: Ziad Abbud, MD         
United States, New York
Mount Sinai New York Not yet recruiting
New York City, New York, United States, 10029
Contact: Samin Sharma, MD       samin.sharma@mountsinai.org   
Contact: Omarys Herasme    212-241-3282    omarys.herasme@mountsinai.org   
Principal Investigator: Samin Sharma, MD         
Saint Elizabeth Medical Center Not yet recruiting
Utica, New York, United States, 13501
Contact: Michael Sassower, MD    315-733-7598    masmdfacc@aol.com   
Contact: Michael Passacantando    315-235-7476    mpassacantando@stemc.org   
Principal Investigator: Michael Sassower, MD         
United States, North Carolina
DukeUniversity Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Manesh Patel, MD    919-668-8917    Manesh.patel@dm.duke.edu   
Contact: Jennifer Hamil    919-681-4680    Jennifer.hamill@duke.edu   
Principal Investigator: Manesh Patel, MD         
North Carolina Heart & Vascular Specialists Not yet recruiting
Raleigh, North Carolina, United States, 27607
Contact: George Adams, MD    919-787-5380    George.adams@rexhealth.com   
Contact: Danielle Matthews    919-231-8253 ext 4001    dmatthews@wakeheartresearch.com   
Principal Investigator: George Adams, MD         
United States, Oklahoma
St. John Health System Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Gaurav Kumar, MD    918-744-3426    Gaurav.kumar@sjmc.org   
Contact: Candida Barlow    918-744-2685    Candida.Barlow@sjmc.org   
Principal Investigator: Gaurav Kumar, MD         
United States, Texas
Mission Research Institute Recruiting
New Braunfels, Texas, United States, 78130
Contact: Jason Yoho, MD         
Contact: Sherie Macht, RN         
Principal Investigator: Jason Yoho, MD         
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: January 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014