Registry to Evaluate the Efficacy of Zotarolimus-Eluting... | NCT00960908

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2012Estimated

Completion Date

Not provided

First Submitted Date

Aug 14, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2009

Last Update Posted Date

Aug 18, 2009Estimated

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.

The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Resolute		Prospective recruitment of Resolute arm will start in March 2009	Device: Endeavor Resolute stents
Endeavor		The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study.	Device: Endeavor Sprint stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endeavor Resolute stents	Device	2nd generation ZES	Resolute	Endeavor Resolute

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)		12 months

Secondary Outcomes

Measure	Description	Time Frame
In-stent & In-segment Late Loss		9 months
Stent Thrombosis		1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient agrees to participate in this study by signing the informed consent form.
Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria:

There are no exclusion criteria for this registry.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyung-Woo Park, MD, PhD	Contact	82-2-2072-0244		kwparkmd@snu.ac.kr
Il-Young Oh, MD	Contact	82-2-2072-3757		spy510@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Hyo-Soo Kim, MD, PhD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital	Not yet recruiting	Anyang			South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases