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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Acute Minimum Stent Area (MSA) — Procedure
In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort. - Target Vessel Failure (TVF) — 1-Year
Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
Trial sites (104)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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