FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
| Tracking Information | |||||
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| First Received Date ICMJE | October 20, 2005 | ||||
| Last Updated Date | November 25, 2011 | ||||
| Start Date ICMJE | November 2001 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00242892 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries | ||||
| Official Title ICMJE | Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure | ||||
| 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. |
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| 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 :
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Coronary Artery Insufficiency | ||||
| Intervention ICMJE | Procedure: Intra coronary measures of pressure
Intra coronary measures of pressure
Other Name: Intra coronary measures of pressure |
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| Study Arm (s) | Experimental: 1
Intra coronary measures of pressure
Intervention: Procedure: Intra coronary measures of pressure |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 800 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00242892 | ||||
| Other Study ID Numbers ICMJE | P001003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Volcano Corporation | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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