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Clinical Trials in the USA / NCT03108456
Active, not recruiting Not applicable

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

NCT03108456 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Not applicable
Started
2017-03-27
Last updated
2023-10-06

Condition(s) studied

Coronary Artery DiseaseIschemic Heart DiseaseNon ST Segment Elevation Myocardial Infarction

Investigational drug(s) / intervention(s)

Orbital AtherectomyBalloon

Orbital Atherectomy: Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation

Balloon: Vessel preparation with conventional and/or specialty balloons

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
General Inclusion Criteria: 1. Subject is 18 years of age or older. 2. Subject presents with: 1. stable ischemic heart disease or 2. acute coronary syndrome (NSTEMI or unstable angina), or 3. stabilized recent STEMI (\>48 hours prior to randomization procedure) 3. Subject has signed the Institutional Review Board (IRB) or Ethics Committee (EC) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures. General Exclusion Criteria 1. Subject has a history of any cognitive or mental health status that would interfere with trial participation. 2. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint. 3. Subject is a female who is pregnant. 4. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure. 5. Subject has a life expectancy of ≤ 12 months. 6. Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization. 7. Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. 8. Any cardiac intervention or cardiac surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy. 9. Subject has major valve disease and underwent intervention within 30 days prior to randomization. 10. Subject has received a heart transplant. 11. Evidence of heart failure by at least one of the following (heart failure assessment is not required per protocol but must be reviewed prior to enrollment if data is available): 1. Most recent LVEF ≤25%, or 2. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or 3. Killip class ≥2 (post STEMI patients) 12. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only. 13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated. 14. Subject has a relative or absolute contraindication to dual antiplatelet therapy or (for patients with atrial fibrillation) single antiplatelet therapy (P2Y12 inhibitor preferred) with an anticoagulant for at least 6 months after PCI. 15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit. 16. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary. 17. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics. 18. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
University of Alabama - Birmingham Birmingham Alabama
Mercy Gilbert Medical Center Chandler Arizona
St. Luke's Medical Center Phoenix Arizona
Arizona Heart Hospital Phoenix Arizona
Yavapai Regional Medical Center Prescott Arizona
Arkansas Heart Hospital Little Rock Arkansas
University of California - San Diego La Jolla California
Cedars-Sinai Medical Center Los Angeles California
Ronald Reagan UCLA Medical Center Los Angeles California
San Francisco VA Medical Center San Francisco California
Denver VA Medical Center Denver Colorado
Colorado Heart and Vascular Lakewood Colorado
Yale New Haven Hospital New Haven Connecticut
Medstar Washington Hospital Center Washington D.C. District of Columbia
The Cardiac & Vascular Institute Research Foundation Gainesville Florida
Memorial Regional Hospital Hollywood Florida
UF Health Jacksonville Jacksonville Florida
Heart Institute at Largo Largo Florida
AdventHealth Ocala Ocala Florida
Florida Hospital Orlando Orlando Florida
Palm Beach Gardens Medical Center Palm Beach Gardens Florida
Tallahassee Research Institute Tallahassee Florida
St. Joseph's Hospital Tampa Florida
Atlanta VA Medical Center Atlanta Georgia
Piedmont Atlanta Hospital Atlanta Georgia
Northeast Georgia Medical Center Gainesville Georgia
University of Illinos - Chicago Chicago Illinois
Loyola University Medical Center Maywood Illinois
Advocate Christ Medical Center Oak Lawn Illinois
Indiana University Indianapolis Indiana
St. Vincent Heart of Indiana Indianapolis Indiana
Community Hospital Munster Indiana
Reid Health Richmond Indiana
Genesis Medical Center Davenport Iowa
Iowa Heart Center West Des Moines Iowa
The University of Kansas Medical Center Kansas City Kansas
U of L Health Louisville Kentucky
Baton Rouge General Medical Center Baton Rouge Louisiana
Cardiovascular Institute of the South Houma Louisiana
Lafayette General Medical Center Lafayette Louisiana

+ 64 more sites — see the full list on the official registry below.

More Abbott Medical Devices trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03108456 on ClinicalTrials.gov ↗ ← All trials in the USA