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OpenTrials
Completed

NCT Number: NCT00242892

FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries

Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.

Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.

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Key information

Conditions

Coronary Artery Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Georges Pompidou's Hospital

Paris, 75015, France

About this study

It is a randomized study, intending to treat, comparing the optimisation of the opening out of a stent into a coronar artery either guided with angiographic images only or with the assistance of pressure measurements plus angiographic control.

Several French centers participate to demonstrate superiority of one strategy. The criterion of principal judgement is the whole of cardiac events, criterion made up with the cardiac death, myocardial infarction, revascularisation by coronary bridging and/or angioplasty and positivity of the effort test.

Secondary criterions are :

  • comparing cost to efficacy of the two strategies
  • evaluating the angiographic restenosis into an under group of 200 patients (100 patients into each group)
  • determining the optimal threshold of measurement of intra coronary pressure in a multicentric population
  • comparing the ability of the different stents used to optimised the intra coronary pressure measurements

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient sent to coronal angioplasty with putting of an active stent to treat a restenosis

Exclusion criteria

  • acute myocardial infarction

Treatment and study plan

Intra coronary measures of pressure

Procedure

Intra coronary measures of pressure

Primary outcomes

  1. The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images

    Time frame: during de study

    The first group of patients will have a coronary procedure with stent and his

Secondary outcomes

  1. At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam

    Time frame: during the study

    At 6 months cardiac events will be registered: patients will undergo a

  2. At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered

    Time frame: during the study

    At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered

  3. Complementary examination

    Time frame: during the study

    Complementary examination

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Volcano Corporation

Registry information

Official study title

Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Oct 21, 2005
Registry last updated
Nov 29, 2011

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.