Coronary Artery InsufficiencyNCT00242892
FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
A study testing Intra coronary measures of pressure in people with Coronary Artery Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Insufficiency
- What is being tested?
- Intra coronary measures of pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2001to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
Who cannot join
- acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Coronary Artery Insufficiency
- Being tested
- Intra coronary measures of pressure
- Keywords
- Deployment stent optimisation, Fractional Flow Reserve, Stent, Restenosis, Coronary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra coronary measures of pressureProcedure or surgery
Intra coronary measures of pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intra coronary measures of pressure Receives: Procedure: Intra coronary measures of pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
The first group of patients will have a coronary procedure with stent and his
Measured: during de study
Secondary outcomes (3)
At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam
At 6 months cardiac events will be registered: patients will undergo a
Measured: during the study
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
Measured: during the study
Complementary examination
Complementary examination
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startNov 2001
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Volcano Corporation
- Responsible party
- Sponsor
- Investigators
- Antoine LAFONT, Pr,MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242892
- Sponsor's protocol ID
- P001003
- Status last verified
- Mar 2007
- First submitted
- 20 Oct 2005
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure
- ClinicalTrials.gov ID
- NCT00242892
- Acronym / sponsor ID
- P001003
- Conditions
- Coronary Artery Insufficiency
- Keywords
- Deployment stent optimisation, Fractional Flow Reserve, Stent, Restenosis, Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Volcano Corporation
- Study start
- Nov 2001
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Intra coronary measures of pressureIntra coronary measures of pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
Key exclusion criteria (1 listed)
- acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra coronary measures of pressureIntra coronary measures of pressure | Procedure or surgery | 1 |
Primary outcome
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
The first group of patients will have a coronary procedure with stent and his
3 secondary outcomes
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
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
Time frame: during the study
Complementary examination
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine LAFONT, Pr,MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra coronary measures of pressure in people with Coronary Artery Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.