PROMUS Element Japan Small Vessel Trial

NCT01080261 | Completed Phase 3 Results DMC

• 1 other identifier: S2069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

Atherosclerosis; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)

  A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.

  9 months

Secondary Outcomes (11)

• Myocardial Infarction (MI) (Percentage of Participants With an Event)

  9 months

• All-cause Death (Percentage of Participants With an Event)

  9 months

• Cardiac Death (Percentage of Participants With an Event)

  9 months

• Target Vessel Revascularization (Percentage of Participants With an Event)

  9 months

• Target Lesion Revascularization (Percentage of Participants With an Event)

  9 months

Study Arms (1)

PROMUS Element

EXPERIMENTAL

everolimus-eluting coronary stent

Device: PROMUS Element

Interventions

PROMUS Element DEVICE

PROMUS Element Everolimus-Eluting Coronary Stent System

PROMUS Element

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Location

Hoshi General Hospital

Koriyama-shi, Fukushima, Japan

Location

Hakodate Municipal Hospital

Hakodate-shi, Hokkaido, Japan

Location

Hokkaido Social Insurance Hospital

Sapporo, Hokkaido, Japan

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Location

Japan Labour Health and Welfare Organization Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, Japan

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Japan Labour Health and Welfare Organization Kumamoto Rosai Hospital

Yatsushiro-shi, Kumamoto, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Kyoto, Japan

Location

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Location

The Cardiovascular Institute Hospital

Minatoku, Tokyo-to, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo-to, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo-tu, Japan

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Results Point of Contact

• Title: Ruth Starzyk, Ph.D.
• Organization: Boston Scientific Corporation

ruth.starzyk@bsci.com

508-683-6577

Study Officials

• Shigeru Saito, MD

  Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 29, 2016
• Results First Posted: April 12, 2012

Record last verified: 2012-08

Locations

JP (15)