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

This study has been completed.
Sponsor:
Collaborator:
Volcano Corporation
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00242892
First received: October 20, 2005
Last updated: November 25, 2011
Last verified: March 2007

October 20, 2005
November 25, 2011
November 2001
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The first group of patients will have a coronary procedure with stent and his
  • The first group of patients will have a coronary procedure with stent and his good deploiement will be controled with angiographics images.
  • For the second group the control will be angiographic plus measures of intra coronary pressure. Measurements of pressure will be taken at each stage of pressure during the deployment of the stent. The stent will have to be released under nominal pressure
  • Specific datas about angioplasty and images will be collected.
Complete list of historical versions of study NCT00242892 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
  • Complementary examination [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Complementary examination
At 6 months cardiac events will be registred : patients will undergo a scintigraphic and effort test with thallium and a clinical exam. At 12 and 18 months they will undergo a clinical exam and cardiac events will be registred. Complementary examinations
Not Provided
Not Provided
 
FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Coronary Artery Insufficiency
Procedure: Intra coronary measures of pressure
Intra coronary measures of pressure
Other Name: Intra coronary measures of pressure
Experimental: 1
Intra coronary measures of pressure
Intervention: Procedure: Intra coronary measures of pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • acute myocardial infarction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00242892
P001003
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Volcano Corporation
Principal Investigator: Antoine LAFONT, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP