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
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).
- Coronary Artery Disease
- Ischemic Heart Disease
- Non ST Segment Elevation Myocardial Infarction
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subject is 18 years of age or older.
- Subject presents with:
- stable ischemic heart disease or
- acute coronary syndrome (NSTEMI or unstable angina), or
- stabilized recent STEMI (>48 hours prior to randomization procedure)
- Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures.
- Subject has a history of any cognitive or mental health status that would interfere with trial participation.
- Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
- Subject is a female who is pregnant.
- Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
- Subject has a life expectancy of ≤ 12 months.
- Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
- Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
- Any cardiac intervention or surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy.
- Subject has major valve disease and underwent intervention within 30 days prior to randomization.
- Subject has received a heart transplant.
- Evidence of heart failure by at least one of the following (note - Left Ventricular Ejection Fraction [LVEF] is not required by protocol):
- Most recent LVEF ≤25%, or
- Current heart failure defined as NYHA class ≥3 (all patients) or Killip class ≥2 (post STEMI patients)
- Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
- Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
- 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).
- Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, or any permanent neurologic deficit.
- Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
- Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
- Subject is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
- Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Orbital Atherectomy (OA)
|The Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.||
Conventional Balloon Angioplasty
|Coronary balloons cleared or approved for commercial use by the Food and Drug Administration will be used for conventional balloon angioplasty prior to implantation of a drug-eluting stent.||
- NCT ID
- Cardiovascular Systems Inc
Study ContactAmber Dickson