FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
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|ClinicalTrials.gov Identifier: NCT00242892|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : November 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Insufficiency||Procedure: Intra coronary measures of pressure||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Intra coronary measures of pressure
Procedure: Intra coronary measures of pressure
Intra coronary measures of pressure
- 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
- 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
- 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
- Complementary examination [ Time Frame: during the study ]Complementary examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242892
|European Georges Pompidou's Hospital|
|Paris, France, 75015|
|Principal Investigator:||Antoine LAFONT, Pr,MD,PhD||Assistance Publique - Hôpitaux de Paris|