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OpenTrials
Completed

NCT Number: NCT00264030

Distal Protection Combined With PTCA in AMI Patients

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Cardiovasculaire Paris Sud

Massy, F - 91300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angioguard distal protection device

Device

PTCA with the Angioguard distal protection device.

Other names: Cordis AngioGuard™ XP

PTCA

Other

PTCA

Primary outcomes

  1. Absolute ST segment resolution.

    Time frame: post-PTCA

Secondary outcomes

  1. ST segment resolution (> 50% decrease).

    Time frame: pre- and post-PTCA

  2. TIMI Frame Count

    Time frame: post PTCA

  3. Composite endpoint of slow flow, no reflow or distal embolization.

    Time frame: at anytime

  4. Regional wall motion index by echocardiography.

    Time frame: discharge and 6 month follow-up

  5. Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.

    Time frame: post-procedure

  6. Cardiac function assessed by echocardiography.

    Time frame: before discharge and at 6 month follow-up

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

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

Acronym: DIPLOMAT

Important dates

Study start
2002
Study completion
2004
First posted
Dec 12, 2005
Registry last updated
Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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