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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Coronary Artery Insufficiency

Treatments: Procedure: Intra coronary measures of pressure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00242892

P001003

Details and patient eligibility

About

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.

Full 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

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• acute myocardial infarction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 1 patient group

1

Experimental group

Description:

Intra coronary measures of pressure

Treatment:

Procedure: Intra coronary measures of pressure