PROMUS Element Japan Small Vessel Trial

Boston Scientific

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Atherosclerosis

Treatments

Device: PROMUS Element

Study type

Interventional

Funder types

Industry

Identifiers

NCT01080261

S2069

Details and patient eligibility

About

A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be at least 20 years of age
Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
Patient is eligible for percutaneous coronary intervention (PCI) with regards to the target lesion Patient is considered suitable for PCI if any of the following criteria meet.
Evidence of ischemia documented with stress electrocardiogram (ECG) and/or any diagnostic imaging tests.
Target vessel supplies blood to relatively large area of the myocardium.
Target lesion is a possible culprit of angina.
Target vessel is a potential collateral source for other major vessels
Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 30 days prior to enrollment
Patient is willing to comply with all protocol-required follow-up evaluation

Exclusion criteria

Patient has clinical symptoms and/or ECG changes consistent with acute myocardial infarction (MI)
Patient has had a known diagnosis of recent MI (i.e., within 72 hours prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
- Patients are excluded if any of the following criteria are met at the time of the index procedure.
- If creatine kinase-myoglobin band (CK-MB) is >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
- If CK MB is 1 2× ULN, the patient is excluded if the CK Total is >2× ULN.
- 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.
- Troponin >1× ULN with at least one of the following.
- Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
- Development of pathological Q waves in the ECG; or
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling the patient.

Patient has received an organ transplant or is on a waiting list for an organ transplant
Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Patient is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) for indications other than acute coronary syndrome
Patient has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3
Patient has a white blood cell (WBC) count <3,000 cells/mm^3
Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
Patient is on dialysis or has known renal insufficiency (i.e., Creatinine > 2.0 mg/dl or >150 μmol/L)
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure (excluding PCI of the non-target lesion within the target vessel treated during the index procedure (Refer to Multiple Interventions During Index Procedure))
Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
Planned PCI or CABG after the index procedure
Patient previously treated at any time with coronary intravascular brachytherapy
Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
Patient has one of the following.
- Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
- Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with the protocol or confound data interpretation
Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Patient with known intention to procreate within 12 months after the index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
Patient has more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure