To study advantage of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in patients with high-risk coronary artery disease.

Phase 4

• Conditions: Health Condition 1: I708- Atherosclerosis of other arteriesHealth Condition 2: I214- Non-ST elevation (NSTEMI) myocardial infarctionHealth Condition 3: I212- ST elevation (STEMI) myocardial infarction of other sites

• Registration Number: CTRI/2020/09/027513
• Lead Sponsor: Abbott India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction) suitable for elective PCI.

3. Patients undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:

A) High clinical-risk, defined as;

Medication-treated diabetes mellitus, AND/OR

B) High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;

i. Target lesion is the culprit lesion responsible for either:

• NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), and >1 mm ST segment deviation and/or dynamic T wave changes at rest within 7 days, OR

• STEMI >24 hours from the onset of ischemic symptoms

ii. long or multiple lesions (defined as intended total stent length in any single target vessel >=28 mm),

iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the main branch and side branch), and where the planned side branch stent is >= 2.5 mm in diameter.

iv. angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion),

v. chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation)

vi. in-stent restenosis (all patterns, as long as the lesion is at or within the stent margin(s) and has an angiographically visually-assessed DS >=70% or DS >=50% with non-invasive or invasive evidence of ischemia)

4. All target lesions (those lesions to be randomized) must have a visually estimated or quantitatively assessed %DS of either >=70%, or >=50% plus one or more of the following: an abnormal functional test (e.g. fractional flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive ACS with plaque disruption or thrombus.

5. All target lesions must be planned for treatment with only >=2.5 mm and <=3.5 mm stents and post-dilatation balloons based on pre-PCI angiographic visual estimation. The only exception is for long target lesions (visually estimated as >20 mm), in which after implantation of a <=3.5 mm stent up to half of the stented segment may be post-dilated with balloons >3.5 mm as needed per operator judgment.

For example, if there is a 34 mm long LAD lesion spanning the proximal and mid segments, a 38 mm long 3.0 mm diameter Xience stent may be implanted, and the proximal half of the stent may be post-dilated with a 3.75 mm balloon.

6. No more than 2 target lesions requiring PCI are present in any single vessel., and no more than 2 target vessels are allowed. Thus, up to 4 randomized target lesions per patient in a maximum of 2 target vessels are allowed, including branches. The intended target lesions will be declared just prior to randomization.

Note: A lesion is defined as any segment(s) of the coronary tree, no matter how long, which is planned to be covered with one contiguous length of stent, whether single or overlapped. A bifurcation counts as a single lesion even if the side

Exclusion Criteria

Clinical exclusion criteria:

1. STEMI <=24 hours from the onset of ischemic symptoms

2. Creatinine clearance <=30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)5 and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.

3. Hypotension, shock or need for mechanical support or intravenous vasopressors

4. CHF (Killip class >=2 or NYHA class >=3)

5. LVEF <=30% by the most recent imaging test within 30 days prior to procedure (echo, MRI, contrast left ventriculography or other)

6. Unstable ventricular arrhythmias

7. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.

8. Planned cardiac or non-cardiac surgery within 24 months after the index procedure

9. Prior PCI within the target vessel within 12 months (unless the target lesion is the prior PCI site - i.e. in-stent restenosis)

10. Any planned PCI within the target vessel(s) within 24 months after the study procedure, other than a planned staged intervention in a second randomized target vessel.

Note: Planned staged interventions must be noted at the time of randomization, and the decision to stage may be modified within 24 hours of completion of the index PCI. See Section 6.5.3.7 for more details of multi lesion and vessel treatment.

Note: PCI in non-target vessels is permitted >48 hours after the index procedure.

11. Any prior PCI in a non-target vessel within 24 hours before the study procedure, or within previous 30 days if unsuccessful or complicated.

Note: Patients requiring non-target vessel PCI may be enrolled and the non-target vessel(s) may be treated in the same index procedure as the randomized lesions (in all cases prior to randomization), as long as treatment of the lesion(s) in the non-target vessel is successful and uncomplicated.

Successful and uncomplicated definition for non-target vessel treatment during the index procedure: Angiographic diameter stenosis <10% and TIMI III flow (visually assessed) for all non-target lesions and vessels, without dissection >= NHLBI type C, perforation, prolonged chest pain ( >5 minutes) or prolonged ST-segment elevation or depression ( >5 minutes), or cardiac arrest or need for defibrillation or cardioversion or hypotension /heart failure requiring mechanical or intravenous hemodynamic support or intubation.

12. Subject has known hypersensitivity or contraindication to any of the study drugs (including heparin and all P2Y12 inhibitors, one or more components of the study devices, including everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoropolymers, or radiocontrast dye that cannot be adequately pre-medicated.

13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

14. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. <br/

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Imaging Outcome: Minimal stent area, continuous measure- Final Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment. <br/ ><br>2. Clinical outcome: Target vessel failure- Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization(ID-TVR), assessed at a minimum of 1 year and up to 2 yearsTimepoint: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 1 year and up to 2 years