Trial Purpose and Description
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).
Ages: 18 years and older
General Inclusion Criteria:
1.Subject is 18 years of age or older. 2.Subject presents with: a.stable ischemic heart disease or b.non-ST elevation acute coronary syndrome, or c.recent (>48 hours) STEMI
3.Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures, per site requirements. 4.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): a.Most recent LVEF ≤25%, or b.Heart failure (NYHA class ≥3 or Killip class ≥2)
12.Planned use of bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only of the randomized lesion(s). 13.Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated. 14.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). 15.Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, 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 is being treated with or will begin treatment with chronic oral anticoagulation (warfarin or NOAC). 18.Subject has evidence of active infection on the day of the index procedure. 19.Subject is not an acceptable candidate for emergent coronary artery bypass graft (CABG). 20.Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and
Cardiovascular Systems, Inc.
Dates: 11/30/2017 - 12/31/2020
Last Updated: 01/02/2018
Study HIC#: 2000020960