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 (ECLIPSE)

• ClinicalTrials.gov Identifier: NCT03108456
• Recruitment Status: Recruiting
• First Posted: April 11, 2017
• Last Update Posted: March 9, 2023
• Sponsor: Cardiovascular Systems Inc
• Collaborator: Cardiovascular Research Foundation, New York
• Information provided by (Responsible Party): Cardiovascular Systems Inc

Tracking Information

• First Submitted Date: February 17, 2017
• First Posted Date: April 11, 2017
• Last Update Posted Date: March 9, 2023
• Actual Study Start Date: March 27, 2017
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2018)

• Acute Minimum Stent Area (MSA) [ Time Frame: 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) [ Time Frame: 1-Year ]
  Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.

Original Primary Outcome Measures (submitted: April 5, 2017)

• Minimum Stent Area (MSA) [ Time Frame: Procedure ]
  In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT).
• Target Vessel Failure (TVF) [ Time Frame: 1-Year ]
  Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or clinically driven target vessel revascularization.

Current Secondary Outcome Measures (submitted: January 12, 2018)

• Procedural Success [ Time Frame: Procedure ]
  Procedural success, defined as successful stent delivery with final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow three (3) and angiographic in-stent diameter stenosis (DS) ≤20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death.
• Strategy Success [ Time Frame: Procedure ]
  Strategy success, defined as procedural success without crossover to alternative treatment.

Original Secondary Outcome Measures (submitted: April 5, 2017)

• Procedural Success [ Time Frame: Procedure ]
  Procedural success, defined as successful stent delivery with final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow three (3) and angiographic in-stent diameter stenosis (DS) ≤20%, and with the absence of any of the following: stent loss, cross-over to alternative strategy, coronary perforation, or intra-procedural death
• Strategy Success [ Time Frame: Procedure ]
  Strategy success, defined as procedural success without crossover or stent loss

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Coronary Artery Disease
• Ischemic Heart Disease
• Non ST Segment Elevation Myocardial Infarction

Intervention

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

Study Arms

• 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.
  Intervention: Device: Orbital Atherectomy
• 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.
  Intervention: Device: Balloon

• Publications *: Genereux P, Kirtane AJ, Kandzari DE, Armstrong EJ, Krucoff MW, Redfors B, Ben-Yehuda O, Lerew DR, Ali ZA, Maehara A, O'Neill WW, Stone GW. Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial. Am Heart J. 2022 Jul;249:1-11. doi: 10.1016/j.ahj.2022.03.003. Epub 2022 Mar 12.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 5, 2017): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

General Inclusion Criteria:

1. Subject is 18 years of age or older.

2. Subject presents with:

   1. stable ischemic heart disease or
   2. acute coronary syndrome (NSTEMI or unstable angina), or
   3. stabilized recent STEMI (>48 hours prior to randomization procedure)
3. Subject has signed the Institutional Review Board (IRB) or Ethics Committee (EC) 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 cardiac 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 (heart failure assessment is not required per protocol but must be reviewed prior to enrollment if data is available):

    1. Most recent LVEF ≤25%, or
    2. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
    3. Killip class ≥2 (post STEMI patients)
12. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
14. Subject has a relative or absolute contraindication to dual antiplatelet therapy or (for patients with atrial fibrillation) single antiplatelet therapy (P2Y12 inhibitor preferred) with an anticoagulant for at least 6 months after PCI.
15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, 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 has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
18. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Krista Stiefel; 651-900-6671; kstiefel@csi360.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03108456
• Other Study ID Numbers: CLN-0011-P
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cardiovascular Systems Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Cardiovascular Systems Inc
• Original Study Sponsor: Same as current
• Collaborators: Cardiovascular Research Foundation, New York

Investigators

• Principal Investigator: Ajay Kirtane, MD, SM; Columbia University Medical Center / New York-Presbyterian Hospital
• Principal Investigator: Philippe Généreux, MD; Morristown Medical Center

• PRS Account: Cardiovascular Systems Inc
• Verification Date: March 2023