The ECLIPSE Trial - Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug- Eluting StEnts
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).
Heart & Vascular,
Heart & Vascular - Interventional Cardiology Trials
John L. Petersen II, MD
General Inclusion Criteria:
- Subject is 18 years of age or older.
Subject presents with:
- stable ischemic heart disease or
- non-ST elevation acute coronary syndrome, or
- recent (>48 hours) STEMI
- Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures, per site requirements.
- Subject agrees to comply with all follow-up visits and trial procedures.
General Exclusion Criteria:
- Subject has the inability to understand the trial requirements or has a history of non-adherence with medical advice.
- 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 and/or breastfeeding or planning to become pregnant within 1-year.
- Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the index procedure.
- Subject has a life expectancy of ≤ twelve (12) months.
- Subject has undergone any prior PCI in the target vessel or its branches within the prior 12 months.
- Subject has undergone an unsuccessful or complicated PCI procedure within 30 days prior to randomization, including during the index procedure.
- 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).
- Subject has experienced an ST-Segment Elevation Myocardial Infarction (STEMI) within 48 hours.
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
- Heart failure (NYHA class ≥3 or Killip class ≥2)
- Planned use of bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only of the randomized lesion(s).
- 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 is being treated with or will begin treatment with chronic oral anticoagulation (warfarin or NOAC).
- Subject has evidence of active infection on the day of the index procedure.
- 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.