Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject is 18 years of age or older.
  2. Subject presents with:
  3. stable ischemic heart disease or
  4. acute coronary syndrome (NSTEMI or unstable angina), or
  5. stabilized recent STEMI (>48 hours prior to randomization procedure)
  6. Subject has signed the Institutional Review Board (IRB) 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 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 (note - Left Ventricular Ejection Fraction [LVEF] is not required by protocol):
  12. Most recent LVEF ≤25%, or
  13. Current heart failure defined as NYHA class ≥3 (all patients) or Killip class ≥2 (post STEMI patients)
  14. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
  15. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
  16. 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).
  17. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, or any permanent neurologic deficit.
  18. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
  19. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
  20. Subject is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
  21. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Device: Orbital Atherectomy
    Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Active Comparator
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.
  • Device: Balloon
    Vessel preparation with conventional and/or specialty balloons

Recruiting Locations

Montefiore-Einstein Medical Center
Bronx, New York 10467
Contact:
Ervin Mazniku

More Details

NCT ID
NCT03108456
Status
Recruiting
Sponsor
Cardiovascular Systems Inc

Study Contact

Amber Dickson
651-202-4135
adickson@csi360.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.