Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)
This study has been completed.
Sponsor:
Cordis Corporation
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00264030
First received: December 9, 2005
Last updated: January 4, 2008
Last verified: January 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Angioguard distal protection device Other: PTCA |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study. |
Resource links provided by NLM:
Further study details as provided by Cordis Corporation:
Primary Outcome Measures:
- Absolute ST segment resolution. [ Time Frame: post-PTCA ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- ST segment resolution (> 50% decrease). [ Time Frame: pre- and post-PTCA ] [ Designated as safety issue: Yes ]
- TIMI Frame Count [ Time Frame: post PTCA ] [ Designated as safety issue: Yes ]
- Composite endpoint of slow flow, no reflow or distal embolization. [ Time Frame: at anytime ] [ Designated as safety issue: Yes ]
- Regional wall motion index by echocardiography. [ Time Frame: discharge and 6 month follow-up ] [ Designated as safety issue: Yes ]
- Clinical success evaluation; qualitative evaluation of device and delivery system characteristics. [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
- Cardiac function assessed by echocardiography. [ Time Frame: before discharge and at 6 month follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 56 |
| Study Start Date: | March 2002 |
| Study Completion Date: | August 2004 |
| Arms | Assigned Interventions |
|---|---|
|
1
PTCA
|
Other: PTCA
PTCA
|
|
2
PTCA with angioguard
|
Device: Angioguard distal protection device
PTCA with the Angioguard distal protection device.
Other Name: Cordis AngioGuard™ XP
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis |
| ClinicalTrials.gov Identifier: | NCT00264030 History of Changes |
| Other Study ID Numbers: | EC00-02 |
| Study First Received: | December 9, 2005 |
| Last Updated: | January 4, 2008 |
| Health Authority: | France: Comite Consultatif de Proection de Personnes dans la Recherche Biomedicale |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013