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RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries (RJ-SVS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01150500
First received: June 23, 2010
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Device: MDT-4107 Zotarolimus-Eluting Coronary Stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RESOLUTE JAPAN SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Target Lesion Failure(TLF) [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • MACE (Major Adverse Cardiac Event) [ Time Frame: Baseline and 9 month ] [ Designated as safety issue: Yes ]
    Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.

  • Late Lumen Loss [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
    Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.

  • Binary Angiographic Restenosis [ Time Frame: Baseline and 9 month ] [ Designated as safety issue: No ]
    Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.

  • Minimum Luminal Diameter [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.

  • Percent Diameter Stenosis [ Time Frame: Baseline and 9 month ] [ Designated as safety issue: Yes ]
    The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).

  • Clinical Endpoints [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis


Enrollment: 65
Study Start Date: June 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent Placement
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
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Other Name: Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150500

Locations
Japan
Shonan Kamakura General Hospital
Kanagawa, Japan, 247-8533
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Shigeru Saito, MD Sohana Kamakura General Hosptial
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01150500     History of Changes
Other Study ID Numbers: MDT2-07-05
Study First Received: June 23, 2010
Results First Received: October 30, 2012
Last Updated: October 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Medtronic Vascular:
Medtronic
Japan
Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Small Vessel Stent

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Ischemia
Myocardial Ischemia
Arteriosclerosis
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014