Coronary Artery DiseasePhase 2DIPLOMATNCT00264030
Distal Protection Combined With PTCA in AMI Patients
A Phase 2 study testing Angioguard distal protection device and PTCA in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in France.
Trial summary
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angioguard distal protection device and PTCA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2002to Aug 2004
- Phase
- Phase 2
- 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
- Acute myocardial infarction < 12 hours with ST segment elevation > 2 mm in at least 2 contiguous leads;
- Clinical indication of primary PTCA;
- De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
- Target lesion stenosis is > 80% (by visual estimation).
Who cannot join
- Patient has unprotected left main coronary disease with > 50% stenosis in case left coronary artery is treated;
- Patient has an ostial target lesion;
- Killip class > 3.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.
Read the detailed description
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- Angioguard distal protection device, PTCA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioguard distal protection deviceDevice
Also called Cordis AngioGuard™ XP
PTCA with the Angioguard distal protection device.
PTCAOther
PTCA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | PTCA Receives: Other: PTCA |
| 2 | Other | PTCA with angioguard Receives: Device: Angioguard distal protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute ST segment resolution.
Measured: post-PTCA
Secondary outcomes (6)
ST segment resolution (> 50% decrease).
Measured: pre- and post-PTCA
TIMI Frame Count
Measured: post PTCA
Composite endpoint of slow flow, no reflow or distal embolization.
Measured: at anytime
Regional wall motion index by echocardiography.
Measured: discharge and 6 month follow-up
Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
Measured: post-procedure
Cardiac function assessed by echocardiography.
Measured: before discharge and at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startMar 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thierry LEFEVRE, MD, Principal investigator, Hopital Tarnier-Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264030
- Sponsor's protocol ID
- EC00-02
- Acronym
- DIPLOMAT
- Status last verified
- Jan 2008
- First submitted
- 9 Dec 2005
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
- ClinicalTrials.gov ID
- NCT00264030
- Acronym / sponsor ID
- DIPLOMAT / EC00-02
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Aug 2004 (actual)
- First posted
- 12 Dec 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.
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.
Detailed description
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: PTCAPTCA |
| 2 | Other | Device: Angioguard distal protection devicePTCA with angioguard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute myocardial infarction < 12 hours with ST segment elevation > 2 mm in at least 2 contiguous leads;
- Clinical indication of primary PTCA;
- De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
- Target lesion stenosis is > 80% (by visual estimation).
Key exclusion criteria (3 listed)
- Patient has unprotected left main coronary disease with > 50% stenosis in case left coronary artery is treated;
- Patient has an ostial target lesion;
- Killip class > 3.
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 |
|---|---|---|
| Angioguard distal protection deviceAlso: Cordis AngioGuard™ XPPTCA with the Angioguard distal protection device. | Device | 2 |
| PTCAPTCA | Other | 1 |
Primary outcome
Absolute ST segment resolution.
Time frame: post-PTCA
6 secondary outcomes
ST segment resolution (> 50% decrease).
Time frame: pre- and post-PTCA
TIMI Frame Count
Time frame: post PTCA
Composite endpoint of slow flow, no reflow or distal embolization.
Time frame: at anytime
Regional wall motion index by echocardiography.
Time frame: discharge and 6 month follow-up
Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
Time frame: post-procedure
Cardiac function assessed by echocardiography.
Time frame: before discharge and at 6 month follow-up
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 7 Jan 2008.
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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.
Thierry LEFEVRE, MD principal investigator
Hopital Tarnier-Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angioguard distal protection device and PTCA in people with Coronary Artery Disease, run by Cordis US Corp. 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 4 inclusion and 3 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 7 Jan 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Absolute ST segment resolution. (time frame: post-PTCA). 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 7 Jan 2008.