Myocardial InfarctionPhase 4NCT00275990
AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction
A Phase 4 study testing rheolytic thrombectomy with direct stenting and direct stenting in people with Myocardial Infarction, run by Boston Scientific Corporation at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- rheolytic thrombectomy with direct stenting and direct stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2005to Aug 2010
- Phase
- Phase 4
- 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 age > 18 years
- ST-segment elevation myocardial infarction
- Angiographically visible thrombus
- Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention
- Patient, or relative or legal guardian,provides written informed consent
- Patient has no childbearing potential or is not pregnant
Who cannot join
- Prior administration of thrombolysis for current MI
- Participation in another Study
- Major surgery within past 6 weeks
- History of stroke within 30 days, or any history of hemorrhagic stroke
- Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy
- Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3)
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- Known prior history of renal insufficiency
- Co-morbidities with expected survival < 1 year
- Patient unwilling to receive blood products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study
The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).
Read the detailed description
Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of most acute myocardial infarctions (AMI). Macro- and microembolization of thrombus during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include percutaneous rheolytic thrombectomy (RT) with the AngioJet catheter before stent implantation. The objectives of the study are: to assess whether RT before direct infarct artery stenting results in improved reperfusion success in patients with acute ST-segment elevation myocardial infarction (STEMI) and angiographically evident thrombus; and to validate a technique for use of the AngioJet RT catheter in the treatment of STEMI.
Comparisons: Treatment with AngioJet RT immediately before direct infarct artery stenting versus direct stenting alone, in patients with STEMI and angiographically visible thrombus presenting within 6 hours of symptom onset for primary PCI.
- Conditions
- Myocardial Infarction
- Being tested
- rheolytic thrombectomy with direct stenting, direct stenting
- Keywords
- coronary thrombectomy, thrombectomy for acute myocardial infarction, C14.280.647.500, C14.907.553.355.500
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rheolytic thrombectomy with direct stentingDevice
direct stentingDevice
| Study group | Role | What they receive |
|---|---|---|
| thrombectomy before stenting | Experimental | thrombectomy before stenting Receives: Device: rheolytic thrombectomy with direct stenting |
| directing stenting alone | Active comparator | directing stenting alone Receives: Device: direct stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
Measured: 30 minutes post procedure
Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days
Measured: 30 days post-procedure
Secondary outcomes (4)
Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count
Measured: post-procedure
30 days- Technetium Tc 99m sestamibi infarct size, MACE
Measured: 30 days post-procedure
6 months- MACE
Measured: 6 months post-procedure
12 months- MACE
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Antoniucci, MD, Principal investigator, Azienda Ospedaliero-Universitaria Careggi, Florence, ITALYAntonio Colombo, MD, Principal investigator, San Raffaelle Hospital, Milan ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275990
- Sponsor's protocol ID
- JETSTENT
- Status last verified
- Oct 2014
- First submitted
- 10 Jan 2006
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004 Apr 15;93(8):1033-5. doi: 10.1016/j.amjcard.2004.01.011.
PubMed 15081450Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, Parodi G, Neumann FJ, Colombo A, Antoniucci D; JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010 Oct 12;56(16):1298-306. doi: 10.1016/j.jacc.2010.06.011. Epub 2010 Aug 5.
PubMed 20691553
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study
- ClinicalTrials.gov ID
- NCT00275990
- Acronym / sponsor ID
- JETSTENT
- Conditions
- Myocardial Infarction
- Keywords
- coronary thrombectomy, thrombectomy for acute myocardial infarction, C14.280.647.500, C14.907.553.355.500
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Jan 2006 (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 purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).
Detailed description
Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of most acute myocardial infarctions (AMI). Macro- and microembolization of thrombus during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include percutaneous rheolytic thrombectomy (RT) with the AngioJet catheter before stent implantation. The objectives of the study are: to assess whether RT before direct infarct artery stenting results in improved reperfusion success in patients with acute ST-segment elevation myocardial infarction (STEMI) and angiographically evident thrombus; and to validate a technique for use of the AngioJet RT catheter in the treatment of STEMI.
Comparisons: Treatment with AngioJet RT immediately before direct infarct artery stenting versus direct stenting alone, in patients with STEMI and angiographically visible thrombus presenting within 6 hours of symptom onset for primary PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrombectomy before stenting | Experimental | Device: rheolytic thrombectomy with direct stentingthrombectomy before stenting |
| directing stenting alone | Active comparator | Device: direct stentingdirecting stenting alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age > 18 years
- ST-segment elevation myocardial infarction
- Angiographically visible thrombus
- Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention
- Patient, or relative or legal guardian,provides written informed consent
Key exclusion criteria (9 listed)
- Prior administration of thrombolysis for current MI
- Participation in another Study
- Major surgery within past 6 weeks
- History of stroke within 30 days, or any history of hemorrhagic stroke
- Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy
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 |
|---|---|---|
| rheolytic thrombectomy with direct stenting | Device | thrombectomy before stenting |
| direct stenting | Device | directing stenting alone |
Primary outcome
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
Time frame: 30 minutes post procedure
Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days
Time frame: 30 days post-procedure
4 secondary outcomes
Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count
Time frame: post-procedure
30 days- Technetium Tc 99m sestamibi infarct size, MACE
Time frame: 30 days post-procedure
6 months- MACE
Time frame: 6 months post-procedure
12 months- MACE
Time frame: 12 months post-procedure
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 9 Oct 2014.
- Background: PubMed 15081450Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004 Apr 15;93(8):1033-5. doi: 10.1016/j.amjcard.2004.01.011.
- Results publication: PubMed 20691553Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, Parodi G, Neumann FJ, Colombo A, Antoniucci D; JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010 Oct 12;56(16):1298-306. doi: 10.1016/j.jacc.2010.06.011. Epub 2010 Aug 5.
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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.
David Antoniucci, MD principal investigator
Azienda Ospedaliero-Universitaria Careggi, Florence, ITALY
Antonio Colombo, MD principal investigator
San Raffaelle Hospital, Milan ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rheolytic thrombectomy with direct stenting and direct stenting in people with Myocardial Infarction, run by Boston Scientific Corporation at 1 site in Italy.
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 6 inclusion and 9 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 9 Oct 2014. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG (time frame: 30 minutes post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00275990, which also lists 2 linked publications.
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 9 Oct 2014.