Back to resultsDistal Protection Combined With PTCA in AMI Patients (DIPLOMAT)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Angioguard distal protection device
PTCA
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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.
Sites / Locations
- Institut Cardiovasculaire Paris Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
PTCA
PTCA with angioguard
Outcomes
Primary Outcome Measures
Absolute ST segment resolution.
Secondary Outcome Measures
ST segment resolution (> 50% decrease).
TIMI Frame Count
Composite endpoint of slow flow, no reflow or distal embolization.
Regional wall motion index by echocardiography.
Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
Cardiac function assessed by echocardiography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00264030
Brief Title
Distal Protection Combined With PTCA in AMI Patients
Acronym
DIPLOMAT
Official Title
Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
PTCA
Arm Title
2
Arm Type
Other
Arm Description
PTCA with angioguard
Intervention Type
Device
Intervention Name(s)
Angioguard distal protection device
Other Intervention Name(s)
Cordis AngioGuard™ XP
Intervention Description
PTCA with the Angioguard distal protection device.
Intervention Type
Other
Intervention Name(s)
PTCA
Intervention Description
PTCA
Primary Outcome Measure Information:
Title
Absolute ST segment resolution.
Time Frame
post-PTCA
Secondary Outcome Measure Information:
Title
ST segment resolution (> 50% decrease).
Time Frame
pre- and post-PTCA
Title
TIMI Frame Count
Time Frame
post PTCA
Title
Composite endpoint of slow flow, no reflow or distal embolization.
Time Frame
at anytime
Title
Regional wall motion index by echocardiography.
Time Frame
discharge and 6 month follow-up
Title
Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
Time Frame
post-procedure
Title
Cardiac function assessed by echocardiography.
Time Frame
before discharge and at 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry LEFEVRE, MD
Organizational Affiliation
Hopital Tarnier-Cochin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Cardiovasculaire Paris Sud
City
Massy
ZIP/Postal Code
F - 91300
Country
France
12. IPD Sharing Statement
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Distal Protection Combined With PTCA in AMI Patients
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