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

NCT ID: NCT00242892

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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

Conditions

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Coronary Artery Insufficiency

Keywords

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Deployment stent optimisation Fractional Flow Reserve Stent Restenosis Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Intra coronary measures of pressure

Group Type EXPERIMENTAL

Intra coronary measures of pressure

Intervention Type PROCEDURE

Intra coronary measures of pressure

Interventions

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Intra coronary measures of pressure

Intra coronary measures of pressure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* acute myocardial infarction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Volcano Corporation

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine LAFONT, Pr,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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European Georges Pompidou's Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P001003

Identifier Type: -

Identifier Source: org_study_id