ST Elevation Acute Myocardial InfarctionPhase 2/3TAAMINCT00650975
ThromboAblation in Acute Myocardial Infarction
A Phase 2/3 study testing Laser Thromboablation and PTCA (Direct Stenting) in people with ST Elevation Acute Myocardial Infarction, run by KCRI at 5 sites in Poland.
Trial summary
1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Acute Myocardial Infarction
- What is being tested?
- Laser Thromboablation and PTCA (Direct Stenting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesPoland
- Study dates
- Mar 2008to Jan 2010
- Phase
- Phase 2/3
- 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
- Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)
- STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.
- Angiographic inclusion criteria after crossing with guidewire:
- IRA is a native coronary artery; and,
- Reference vessel diameter 2.5 - 4.0 mm; and,
- TIMI 0 or 1 flow with any TIMI thrombus grade; or,
- TIMI 2 or 3 flow with TIMI thrombus grade 3 or greater
Who cannot join
- Patient unwilling or unable to give informed consent
- Previous MI in the distribution of the current IRA
- Previous CABG
- Contraindications to PCI
- allergy(s) to intended study medications
- contraindicated for stent implantation
Show all 21Show fewer
- Active bleeding or coagulopathy
- Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP or vasopressors)
- Known left ventricular ejection fraction (EF) <30%
- Fibrinolytic administered before PCI
- Renal insufficiency (creatinine >2.0mg/dl)
- Current vitamin K antagonist therapy or known INR >1.5
- Known thrombocytopenia - platelets <100,000 cell count
- Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
- Known history of hemorrhagic stroke (CVA or TIA) <2 years before screening
- Known or suspected pregnancy
- Current cancer disease
- Comorbidity where survival is anticipated to be <1 year.
- No future patient cooperation expected
- Patient is participating in another clinical study
- Patient <18 years of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
Katowice, 40-635
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
Krakow, 31-202
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, 31-501
University Hospital No. 1 1st Dept. of Cardiology
Poznan, 61-848
Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory
Warsaw, 04-628
About this study
- Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
- Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).
- Conditions
- ST Elevation Acute Myocardial Infarction
- Being tested
- Laser Thromboablation, PTCA (Direct Stenting)
- Keywords
- STEMI, Laser, Thrombus, Thrombectomy
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ThromboablationDevice
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
PTCA (Direct Stenting)Device
Also called PCI, Direct Stenting
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
| Study group | Role | What they receive |
|---|---|---|
| ELCA | Active comparator | Laser Thromboablation Receives: Device: Laser Thromboablation |
| PTCA | Active comparator | PTCA (Direct Stenting) Receives: Device: PTCA (Direct Stenting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Measured: 60 minutes - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Study completionJan 2010
Why it stopped: Slow enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Acute Myocardial InfarctionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCRI
- Sponsor type
- University, hospital or other
- Collaborators
- Spectranetics Corporation
- Investigators
- Dariusz Dudek, MD, PhD, Principal investigator, Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650975
- Sponsor's protocol ID
- D001747-01
- Acronym
- TAAMI
- Status last verified
- Jan 2011
- First submitted
- 26 Mar 2008
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThromboAblation in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00650975
- Acronym / sponsor ID
- TAAMI / D001747-01
- Conditions
- ST Elevation Acute Myocardial Infarction
- Keywords
- STEMI, Laser, Thrombus, Thrombectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment rate.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- KCRIUniversity, hospital or other
- Collaborators
- Spectranetics Corporation
- Study start
- Mar 2008
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Apr 2008 (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.
- Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
- Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELCA | Active comparator | Device: Laser ThromboablationLaser Thromboablation |
| PTCA | Active comparator | Device: PTCA (Direct Stenting)PTCA (Direct Stenting) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)
- STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.
- IRA is a native coronary artery; and,
- Reference vessel diameter 2.5 - 4.0 mm; and,
- TIMI 0 or 1 flow with any TIMI thrombus grade; or,
Key exclusion criteria (21 listed)
- Patient unwilling or unable to give informed consent
- Previous MI in the distribution of the current IRA
- Previous CABG
- Contraindications to PCI
- Active bleeding or coagulopathy
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 |
|---|---|---|
| Laser ThromboablationLaser Thromboablation using the Spectranetics CVX-300® excimer laser system | Device | ELCA |
| PTCA (Direct Stenting)Also: PCI, Direct StentingBalloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use | Device | PTCA |
Primary outcome
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Time frame: 60 minutes - 30 days
Results and safety
The study was stopped early (reason given: Slow enrollment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
Related trials for ST Elevation Acute Myocardial Infarction
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingPhase 4
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
ST Elevation Myocardial Infarction (STEMI)
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Not yet recruitingObservational study
On vs Off-hour PPCI in STEMI Patients
Acute STEMI, PPCI
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.
Dariusz Dudek, MD, PhD principal investigator
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Laser Thromboablation and PTCA (Direct Stenting) in people with ST Elevation Acute Myocardial Infarction, run by KCRI at 5 sites in Poland.
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 7 inclusion and 21 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: stopped early, as of the sponsor's last update on 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Slow enrollment rate.). Results are not available in the source record.
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?
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE (time frame: 60 minutes - 30 days). 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 20 Jan 2011.