Drug-eluting Stents to Treat Unprotected Coronary Left Ma... | NCT00598637

Studies
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

NCT00598637

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Jul 2, 2013Estimated

Enrollment

650Actual

Phase

Phase 4

Conditions

Coronary Disease

Interventions

Everolimus-eluting stent (Xience)
Zotarolimus-eluting stent (Endeavor Resolute)

Countries

Germany
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 21, 2008

First Posted Date

Jan 22, 2008Estimated

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

Jul 1, 2013

Last Update Posted Date

Jul 2, 2013Estimated

Name	Class
Technical University of Munich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.

Detailed Description

Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

650Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EES	Active Comparator	Everolimus-eluting stent (Xience)	Device: Everolimus-eluting stent (Xience)
ZES	Experimental	Zotarolimus-eluting stent (Endeavor Resolute)	Device: Zotarolimus-eluting stent (Endeavor Resolute)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Everolimus-eluting stent (Xience)	Device	stent is implanted due to randomization	EES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.		1 year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Angiographic restenosis at follow-up coronary angiography.		6-9 months follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness.
Pretreatment with a loading dose of 600 mg clopidogrel.
Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

Cardiogenic shock.
ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
In-stent restenosis.
Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
Prior coronary artery bypass surgery with revascularization of LAD and/or LCx.
Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment.
Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media.
Pregnancy (present, suspected or planned).
Patient's inability to fully cooperate with the study protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen	Study Chair
Julinda Mehill, MD	Deutsches Herzzentrum Muenchen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bad Segeberger Kliniken		Bad Segeberg			Germany
Deutsches Herzzentrum Muenchen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11583882	Background	Park SJ, Hong MK, Lee CW, Kim JJ, Song JK, Kang DH, Park SW, Mintz GS. Elective stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance. J Am Coll Cardiol. 2001 Oct;38(4):1054-60. doi: 10.1016/s0735-1097(01)01491-7.
9426015	Background

ID	Term
D003327	Coronary Disease
D003324	Coronary Artery Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases