Distal Protection Combined With PTCA in AMI Patients | NCT00264030

Studies
Distal Protection Combined With PTCA in AMI Patients

NCT00264030

Sponsor

Cordis US Corp.

Status

Completed

Last Update Posted

Jan 7, 2008Estimated

Enrollment

56Actual

Phase

Phase 2

Conditions

Coronary Artery Disease

Interventions

Angioguard distal protection device
PTCA

Countries

France

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

Jan 2008

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

Mar 2002

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Dec 9, 2005

First Submission Date that Met QC Criteria

Dec 9, 2005

First Posted Date

Dec 12, 2005Estimated

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

Jan 4, 2008

Last Update Posted Date

Jan 7, 2008Estimated

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 primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

Detailed Description

This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	PTCA	Other: PTCA
2	Other	PTCA with angioguard	Device: Angioguard distal protection device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angioguard distal protection device	Device	PTCA with the Angioguard distal protection device.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute ST segment resolution.		post-PTCA

Secondary Outcomes

Measure	Description	Time Frame
ST segment resolution (> 50% decrease).		pre- and post-PTCA
TIMI Frame Count		post PTCA
Composite endpoint of slow flow, no reflow or distal embolization.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myocardial infarction < 12 hours with ST segment elevation > 2 mm in at least 2 contiguous leads;
Clinical indication of primary PTCA;
De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
Target lesion stenosis is > 80% (by visual estimation).

Exclusion Criteria:

Patient has unprotected left main coronary disease with > 50% stenosis in case left coronary artery is treated;
Patient has an ostial target lesion;
Killip class > 3.

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
Thierry LEFEVRE, MD	Hopital Tarnier-Cochin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Cardiovasculaire Paris Sud		Massy		F - 91300	France

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided