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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Keywords

Coronary Artery Disease Ischemic Heart Disease Non ST Segment Elevation Myocardial Infarction atherectomy CAD severe calcium orbital atherectomy minimum stent area Infarction Myocardial Ischemia Coronary Disease Heart Diseases Myocardial Infarction

Eligibility

For people ages 18 years and up

General Inclusion Criteria:

  1. Subject is 18 years of age or older.
  2. Subject presents with:
  3. stable ischemic heart disease or
  4. non-ST elevation acute coronary syndrome, or
  5. recent (>48 hours) STEMI
  6. Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures, per site requirements.
  7. Subject agrees to comply with all follow-up visits and trial procedures.

General Exclusion Criteria:

  1. Subject has the inability to understand the trial requirements or has a history of non-adherence with medical advice.
  2. Subject has a history of any cognitive or mental health status that would interfere with trial participation.
  3. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
  4. Subject is a female who is pregnant and/or breastfeeding or planning to become pregnant within 1-year.
  5. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the index procedure.
  6. Subject has a life expectancy of ≤ twelve (12) months.
  7. Subject has undergone any prior PCI in the target vessel or its branches within the prior 12 months.
  8. Subject has undergone an unsuccessful or complicated PCI procedure within 30 days prior to randomization, including during the index procedure.
  9. Any cardiovascular intervention is planned within 1 year post index procedure aside from a potential planned staged PCI as part of the randomized treatment strategy (see staged and multilesion / multivessel procedure section).
  10. . Subject has experienced an ST-Segment Elevation Myocardial Infarction (STEMI) within 48 hours.
  11. . Evidence of heart failure by at least one of the following (note - Left Ventricular

Ejection Fraction [LVEF] is not required by protocol):

  1. Most recent LVEF ≤25%, or
  2. Heart failure (NYHA class ≥3 or Killip class ≥2)
  3. . Planned use of bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only of the randomized lesion(s).
  4. . Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
  5. . Subject has a relative or absolute contraindication to aspirin or all P2Y12 inhibitor agents, or will be unable to take both aspirin and a P2Y12 inhibitor for at least 6 months after PCI (e.g., due to a planned surgical procedure).
  6. . Subject has a history of a stroke or transient ischemic attack (TIA) within six (6)months, or any permanent neurologic deficit.
  7. . Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
  8. . Subject is being treated with or will begin treatment with chronic oral anticoagulation (warfarin or NOAC).
  9. . Subject has evidence of active infection on the day of the index procedure.
  10. . Subject is not an acceptable candidate for emergent coronary artery bypass graft(CABG).
  11. . Subject with known allergy to atherectomy lubricant components including soybean oil,egg yolk phospholipids, glycerin and sodium hydroxide.

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco, California, 942121, United States
  • University of California - San Diego accepting new patients
    La Jolla, California, 92037, United States
  • St. Luke's Medical Center accepting new patients
    Phoenix, Arizona, 85006, United States
  • Mercy Gilbert Medical Center accepting new patients
    Chandler, Arizona, 85224, United States
  • Swedish Medical Center accepting new patients
    Seattle, Washington, 98122, United States
  • Colorado Heart and Vascular accepting new patients
    Lakewood, Colorado, 80228, United States
  • Oklahoma Heart Hospital accepting new patients
    Oklahoma City, Oklahoma, 73120, United States
  • St. John's Health System accepting new patients
    Tulsa, Oklahoma, 74104, United States
  • Methodist Health accepting new patients
    Dallas, Texas, 75203, United States
  • Dallas VA Medical Center accepting new patients
    Dallas, Texas, 75216, United States
  • Iowa Heart Center accepting new patients
    West Des Moines, Iowa, 50266, United States
  • Houston Methodist accepting new patients
    Houston, Texas, 77030, United States
  • Metropolitan Cardiology Consultants accepting new patients
    Coon Rapids, Minnesota, 55433, United States
  • Arkansas Heart Hospital accepting new patients
    Little Rock, Arkansas, 72211, United States
  • Barnes-Jewish Hospital accepting new patients
    Saint Louis, Missouri, 63110, United States
  • Cardiovascular Institute of the South accepting new patients
    Houma, Louisiana, 70360, United States
  • Ochsner Medical accepting new patients
    New Orleans, Louisiana, 70121, United States
  • Indiana University accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Ascension St. John Hospital and Medical Center accepting new patients
    Detroit, Michigan, 48236, United States
  • Piedmont Atlanta Hospital accepting new patients
    Atlanta, Georgia, 30309, United States
  • Atlanta VA Medical Center accepting new patients
    Atlanta, Georgia, 30033, United States
  • Tallahassee Research Institute accepting new patients
    Tallahassee, Florida, 32308, United States
  • Charleston Area Medical Center accepting new patients
    Charleston, West Virginia, 25304, United States
  • Allegheny General Hospital accepting new patients
    Pittsburgh, Pennsylvania, 15212, United States
  • The Cardiac & Vascular Institute Research Foundation accepting new patients
    Gainesville, Florida, 32605, United States
  • St. Joseph's Hospital accepting new patients
    Tampa, Florida, 33614, United States
  • Duke University Medical Center accepting new patients
    Durham, North Carolina, 27705, United States
  • Durham VA Medical Center accepting new patients
    Durham, North Carolina, 27705, United States
  • WakeMed accepting new patients
    Raleigh, North Carolina, 27610, United States
  • Florida Hospital Orlando accepting new patients
    Orlando, Florida, 32806, United States
  • Orlando Health accepting new patients
    Orlando, Florida, 32806, United States
  • Medstar Washington Hospital Center accepting new patients
    Washington, District of Columbia, 20010, United States
  • Sentara Cardiovascular accepting new patients
    Norfolk, Virginia, 23507, United States
  • Penn Presbyterian Medical Center accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Palm Beach Gardens Medical Center accepting new patients
    Palm Beach Gardens, Florida, 33410, United States
  • Morristown Medical Center accepting new patients
    Morristown, New Jersey, 07962, United States
  • Hackensack University Medical Center accepting new patients
    Hackensack, New Jersey, 07601, United States
  • Northwell Health accepting new patients
    New York, New York, 10075, United States
  • Columbia University Medical Center / New York-Presbyterian Hospital accepting new patients
    New York, New York, 10032, United States
  • St. Francis Hospital accepting new patients
    Roslyn, New York, 11576, United States
  • Yale New Haven Hospital accepting new patients
    New Haven, Connecticut, 06516, United States
  • University of Massachusetts Worcester accepting new patients
    Worcester, Massachusetts, 01655, United States
  • Maine Medical Center accepting new patients
    Portland, Maine, 04021, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cardiovascular Systems Inc
ID
NCT03108456
Study Type
Interventional
Last Updated
December 6, 2017
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