A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions

Phase 3

Completed

• Conditions: atherosclerosis; coronary disease; 10011082; 10007593

• Registration Number: NL-OMON33929
• Lead Sponsor: Boston Scientific Cooperation International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Patient must be at least 18 years of age.
2. Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C
3. Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment
4. No more than 2 de novo target lesions in 2 separate native epicardial vessels may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
5. No more than 1 de novo non-target lesion in 1 non-target vessel may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
6. Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) as follows:
o >=2.50 mm and <=4.25 mm for the RCT (WH selection criteria)
o >=2.25 mm and <2.50 mm for the non-randomized SV subtrial (SV selection criteria)
o >=2.50 mm and <=4.25 mm for the non-randomized LL subtrial (LL selection criteria)
7. Target lesion length must measure (by visual estimate):
o <=24 mm for the RCT (WH selection criteria)
o <=28 mm for the non-randomized SV subtrial (SV selection criteria)
o >24 mm and <=34 mm for the non-randomized LL subtrial (LL selection criteria)
8. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.

Exclusion Criteria

1. Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI.
2. Patient has had a known diagnosis of recent MI (ie, within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
o Patients are excluded if any of the following criteria are met at the time of the index procedure.
o If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
o If CK MB is 1 2× ULN, the patient is excluded if the CK Total is >2× ULN.
o If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at the time of the index procedure.
o Troponin >1× ULN with at least one of the following.
o Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
o Development of pathological Q waves in the ECG; or
o Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
3. Patient has received an organ transplant or is on a waiting list for an organ transplant.
4. Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
5. Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, etc.).
6. Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome.
7. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
8. Patient has a white blood cell (WBC) count <3,000 cells/mm3.
9. Patient has documented or suspected liver disease, including laboratory evidence of hepatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Twelve-month target lesion failure (TLF) rate, defined as any ischemia-driven<br /><br>revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave<br /><br>and non-Q-wave) related to the target vessel, or cardiac death related to the<br /><br>target vessel.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical endpoints measured in hospital and at 30 days, 6 months, 12 months, 18<br /><br>months, 2 years, 3 years, 4 years, and 5 years in the RCT and non-randomized SV<br /><br>and LL subtrials:<br /><br>• TLR rate<br /><br>• TLF rate (primary endpoint at 12 months)<br /><br>• Target vessel revascularization (TVR) rate<br /><br>• Target vessel failure (TVF) rate<br /><br>• MI (Q-wave and non-Q-wave) rate<br /><br>• Cardiac death rate<br /><br>• Non-cardiac death rate<br /><br>• All death rate<br /><br>• Cardiac death or MI rate<br /><br>• All death or MI rate<br /><br>• All death/MI/TVR rate<br /><br>• Stent thrombosis rate (definite or probable by Academic Research Consortium<br /><br>[ARC] definitions)<br /><br>Periprocedural endpoints measured in the RCT and non-randomized SV and LL<br /><br>subtrials:<br /><br>• Technical success rate<br /><br>Clinical procedural success rate</p><br>