Distal Protection Combined With PTCA in AMI Patients

Coronary Artery Disease Clinical Trial

— DIPLOMAT  

Official title:

Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264030
• Other study ID #: EC00-02
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2005
• Last updated: January 4, 2008
• Start date: March 2002
• Est. completion date: August 2004

Study information

• Verified date: January 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comite Consultatif de Proection de Personnes dans la Recherche Biomedicale
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Angioguard distal protection device
PTCA with the Angioguard distal protection device.

Other:
• PTCA
PTCA

Locations

Country	Name	City	State
France	Institut Cardiovasculaire Paris Sud	Massy

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute ST segment resolution.		post-PTCA	Yes
Secondary	ST segment resolution (> 50% decrease).		pre- and post-PTCA	Yes
Secondary	TIMI Frame Count		post PTCA	Yes
Secondary	Composite endpoint of slow flow, no reflow or distal embolization.		at anytime	Yes
Secondary	Regional wall motion index by echocardiography.		discharge and 6 month follow-up	Yes
Secondary	Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.		post-procedure	Yes
Secondary	Cardiac function assessed by echocardiography.		before discharge and at 6 month follow-up	Yes