A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population

NCT01115933 | Completed Results

• 1 other identifier: 09-385
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.

Conditions

Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

drug eluting stents; small vessel; Stents; Everolimus; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)

  Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)

  9 Months

Secondary Outcomes (39)

• Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)

  The period during an in-hospital stay of less than or equal to 7 days post index procedure.

• Procedural Success(Subject Base Analysis)

  The period during an in-hospital stay of less than or equal to 7 days post index procedure.

• Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal

  8 months

• Late Loss (LL), In-segment, In-stent, Proximal and Distal

  8 months

• Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal

  8 months

Study Arms (1)

XIENCE PRIME SV EECSS

EXPERIMENTAL

XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System

Device: XIENCE PRIME SV EECSS

Interventions

XIENCE PRIME SV EECSS DEVICE

Patients receiving XIENCE PRIME SV EECSS

XIENCE PRIME SV EECSS

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 20 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must agree to undergo all protocol-required follow-up procedures.
• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
• One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.
• Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1.
• Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and \< 2.5 mm.
• Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

You may not qualify if:

• Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
• The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
• Subject has a known left ventricular ejection fraction (LVEF) \< 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
• Subject has received coronary brachytherapy in any epicardial vessel.
• Subject has received any organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
• Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
• Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin).
• Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
• Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel.
• Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell (WBC) of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
• Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 mg/dL, or on dialysis).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (14)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Hokkaido Social Insurance Hospital Cardiovascular Center

Toyohira, Hokkaido, Japan

Location

Teikyo University

Tokyo, Itabashi, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Saiseikai Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Kumamoto Central Hospital

Kumamoto, Kumamoto, Japan

Location

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

Nagoya Daini Red Cross Hospital

Shōwaku, Nagoya, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Location

Sakurabashi Watanabe Hospital

Kita-ku, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Tokushima Red Cross Hospital

Komatsushimachō, Tokushima, Japan

Location

MeSH Terms

Conditions

Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: David R Rutledge
• Organization: Abbott Vascular

david.rutledge@av.abbott.com

(408) 845-3820

Study Officials

• Takaaki Isshiki, MD

  Teikyo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2013
• Last Updated: August 13, 2015
• Results First Posted: January 3, 2014

Record last verified: 2015-06

Locations

JP (14)