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
  Purpose

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.


Condition Intervention
Coronary Artery Insufficiency
Procedure: Intra coronary measures of pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 800
Study Start Date: November 2001
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intra coronary measures of pressure
Procedure: Intra coronary measures of pressure
Intra coronary measures of pressure
Other Name: Intra coronary measures of pressure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute myocardial infarction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242892

Locations
France
European Georges Pompidou's Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Volcano Corporation
Investigators
Principal Investigator: Antoine LAFONT, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00242892     History of Changes
Other Study ID Numbers: P001003
Study First Received: October 20, 2005
Last Updated: November 25, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Deployment stent optimisation
Fractional Flow Reserve
Stent
Restenosis
Coronary

ClinicalTrials.gov processed this record on July 24, 2014