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

Not Applicable

Completed

• Conditions: Coronary Artery Insufficiency
• Interventions: Procedure: Intra coronary measures of pressure

• Registration Number: NCT00242892
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-21
• Status Verified: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Last Update Submitted: 2011-11-25
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

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

Read More

Exclusion Criteria

• acute myocardial infarction

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intra coronary measures of pressure	Intra coronary measures of pressure

Primary Outcome Measures

Name	Time	Method
The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images	during de study	The first group of patients will have a coronary procedure with stent and his

Secondary Outcome Measures

Name	Time	Method
At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam	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	during the study	At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
Complementary examination	during the study	Complementary examination

Trial Locations

Locations (1)

European Georges Pompidou's Hospital; 🇫🇷 Paris, France