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

Abbott

Status: Active, not recruiting

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Non ST Segment Elevation Myocardial Infarction

Treatments: Device: Orbital Atherectomy; Device: Balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03108456

CLN-0011-P

Details and patient eligibility

About

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).

Enrollment: 2,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,005 participants in 2 patient groups

Orbital Atherectomy (OA)

Active Comparator group

Description:

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.

Treatment:

Device: Orbital Atherectomy

Conventional Balloon Angioplasty

Active Comparator group

Description:

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.

Treatment:

Device: Balloon