Clinical trial NCT00242892: FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Official title: Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Insufficiency
Keywords: Deployment stent optimisation
Fractional Flow Reserve
Stent
Restenosis
Coronary
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Volcano Corporation
First posted: 2005-10-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* acute myocardial infarction

Primary outcomes:
measure: The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
timeFrame: during de study
Secondary outcomes:
measure: At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam
timeFrame: during the study
measure: At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
timeFrame: during the study
measure: Complementary examination
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: European Georges Pompidou's Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine LAFONT, Pr,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: