RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

NCT01150500 | Completed Results DMC

• 1 other identifier: MDT2-07-05
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.

Conditions

Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease

Keywords

Medtronic; Japan; Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Small Vessel Stent

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure(TLF)

  Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)

  9 month

Secondary Outcomes (6)

• MACE (Major Adverse Cardiac Event)

  Baseline and 9 month

• Late Lumen Loss

  Baseline and 9 months

• Binary Angiographic Restenosis

  Baseline and 9 month

• Minimum Luminal Diameter

  9 month

• Percent Diameter Stenosis

  Baseline and 9 month

Study Arms (1)

Drug Eluting Stent

EXPERIMENTAL

Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.

Device: MDT-4107 Zotarolimus-Eluting Coronary Stent

Interventions

MDT-4107 Zotarolimus-Eluting Coronary Stent DEVICE

Also known as: Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic

Drug Eluting Stent

Eligibility Criteria

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

You may qualify if:

• Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
• Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
• Informed consent
• Patient agrees to comply with specified follow-up evaluations at same investigational site
• Single target lesion or two target lesions located in separate coronary arteries
• De novo lesion(s) in native coronary artery(ies)
• Target lesion(s) ≤ 27 mm in length
• Target vessel(s) have reference vessel diameter 2.25 mm to 3.5 mm

You may not qualify if:

• Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; White Blood Cell (wbc) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
• Acute myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(CK-MB) \> lab upper limit of normal)
• Previous PCI of target vessel(s) within 9 months prior to the procedure
• Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
• History of stroke or transient ischemic attack(TIA) within prior 6 months
• Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
• Inability to comply with required trial antiplatelet regimen
• Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
• Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
• Unprotected left main coronary artery disease

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

Shonan Kamakura General Hospital

Kanagawa, 247-8533, Japan

Location

Related Publications (1)

• Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27.

  PMID: 25428602 DERIVED

Related Links

• Medtronic Clinical Trials Link

MeSH Terms

Conditions

Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Heart Diseases; Coronary Disease; Arteriosclerosis

Results Point of Contact

• Title: Hiroko Ookubo
• Organization: Study Manager

hiroko.ookubo@medtronic.com

+81-3-6430-7017

Study Officials

• Shigeru Saito, MD

  Sohana Kamakura General Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: June 23, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2016
• Last Updated: March 14, 2017
• Results First Posted: November 30, 2012

Record last verified: 2017-02

Locations

JP (1)