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

Coronary Artery Disease Clinical Trial

— RJ-SVS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01150500
• Other study ID #: MDT2-07-05
• Status: Active, not recruiting
• Phase: N/A
• First received: June 23, 2010
• Last updated: April 8, 2016
• Start date: June 2010
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: June 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• MDT-4107 Zotarolimus-Eluting Coronary Stent

Locations

Country	Name	City	State
Japan	Shonan Kamakura General Hospital	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	MACE (Major Adverse Cardiac Event)	Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.	Baseline and 9 month	Yes
Secondary	Late Lumen Loss	Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.	Baseline and 9 months	No
Secondary	Binary Angiographic Restenosis	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.	Baseline and 9 month	No
Secondary	Minimum Luminal Diameter	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.	9 month	No
Secondary	Percent Diameter Stenosis	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).	Baseline and 9 month	Yes
Secondary	Clinical Endpoints	Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis	5 Years	Yes

External Links

•   Medtronic Clinical Trials Link
•   Medtronic Japan