Acute Coronary SyndromeHAT-TRICK-OCTNCT01391871
Vascular Healing of DES at 3 Months
An observational study of Acute Coronary Syndrome, run by University of Turku at 2 sites in Finland.
Trial summary
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- OCT and Transthoracic echocardiography CFR measurement
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 46 participants
- Where
- 2 sitesFinland
- Study dates
- Jun 2011to Jul 2013
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome treated with PRO-Kinetic DES or Endeavor Resolute DES during index PCI.
Who may be able to join
- STEMI or NSTEMI or unstable angina
- Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board.
- Single de novo or non-stented restenosis lesion of LAD
- Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be treated prior to the index target vessel treatment.
- Target lesion (maximum 20 mm length by visual estimate) to be covered by a single stent of maximum 23mm length.
- Reference vessel diameter must be >2.5mm and <4.0mm by visual estimate.
- The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected.
- Target lesion >50% and <100% stenosed by visual estimate.
Who cannot join
- Pre-existing diagnosis of diabetes irrespective of its type.
- Impaired renal function (serum creatinine >177micromol/l) or on dialysis
- Platelet count < 10 e5 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated.
- Patient has received organ transplant or is on a waiting list for any organ transplant.
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel, stainless steel alloy, or contrast agent that cannot be adequately pre-medicated.
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- Patient presents with cardiogenic shock.
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
- Currently participating in another investigational drug or device study.
- Unprotected left main disease.
- Ostial target lesions.
- Chronic total occlusion.
- Calcified target lesions that cannot be adequately pre-dilated.
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
- Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter.
- A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Satakunta Central Hospital, Pori
Pori, 28500
Turku University Hospital
Turku, 20520
About this study
Official title: A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 3 Months After Deployment of PRO-Kinetic Drug-eluting Stent and Endeavor Resolute Zotarolimus-eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
Read the detailed description
Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndrome.
Design: A prospective, randomized and controlled study comparing coronary flow reserve and coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12 months.
Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.
Secondary clinical endpoints: MACE and stent thrombosis.
Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute DES).
- Conditions
- Acute Coronary Syndrome
- Being tested
- OCT, Transthoracic echocardiography CFR measurement
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Optical coherence tomography
Transthoracic echocardiography CFR measurementDevice
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
| Study group | Role | What they receive |
|---|---|---|
| PRO-Kinetic DES | Patients receiving PRO-Kinetic drug-eluting stent Receives: Device: OCT; Device: Transthoracic echocardiography CFR measurement | |
| Endeavor Resolute DES | Patient receiving Endeavor Resolute zotarolimus-eluting stent Receives: Device: OCT; Device: Transthoracic echocardiography CFR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncovered stent struts
Percentage of uncovered stent struts per stent by OCT
Measured: 3 months
Coronary flow reserve
Coronary flow reserve by transthoracic echocardiography.
Measured: 3 months
Secondary outcomes (1)
MACE and target vessel stent thrombosis
Death, MI (Q wave or non-Q wave), emergent CABG, or justified TLR by repeat PCI or CABG, and target vessel stent thrombosis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital District of Satakunta
- Responsible party
- Principal investigator, Tuomas Kiviniemi, University of Turku
- Investigators
- Tuomas Kiviniemi, MD, PhD, Principal investigator, Turku University HospitalPasi Karjalainen, MD, PhD, Principal investigator, Satakunta Central HospitalAntti Ylitalo, MD, PhD, Principal investigator, Satakunta Central HospitalJuhani Airaksinen, MD, PhD, FESC, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391871
- Sponsor's protocol ID
- HAT-TRICK-OCT
- Acronym
- HAT-TRICK-OCT
- Status last verified
- Aug 2013
- First submitted
- 7 Jul 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 3 Months After Deployment of PRO-Kinetic Drug-eluting Stent and Endeavor Resolute Zotarolimus-eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
- ClinicalTrials.gov ID
- NCT01391871
- Acronym / sponsor ID
- HAT-TRICK-OCT / HAT-TRICK-OCT
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- The Hospital District of Satakunta
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2011 (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 compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
Detailed description
Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndrome.
Design: A prospective, randomized and controlled study comparing coronary flow reserve and coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12 months.
Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.
Secondary clinical endpoints: MACE and stent thrombosis.
Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute DES).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO-Kinetic DES | – | Device: OCT, Device: Transthoracic echocardiography CFR measurementPatients receiving PRO-Kinetic drug-eluting stent |
| Endeavor Resolute DES | – | Device: OCT, Device: Transthoracic echocardiography CFR measurementPatient receiving Endeavor Resolute zotarolimus-eluting stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome treated with PRO-Kinetic DES or Endeavor Resolute DES during index PCI.
Key inclusion criteria (8 listed)
- STEMI or NSTEMI or unstable angina
- Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board.
- Single de novo or non-stented restenosis lesion of LAD
- Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be treated prior to the index target vessel treatment.
- Target lesion (maximum 20 mm length by visual estimate) to be covered by a single stent of maximum 23mm length.
Key exclusion criteria (16 listed)
- Pre-existing diagnosis of diabetes irrespective of its type.
- Impaired renal function (serum creatinine >177micromol/l) or on dialysis
- Platelet count < 10 e5 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated.
- Patient has received organ transplant or is on a waiting list for any organ transplant.
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 |
|---|---|---|
| OCTOptical coherence tomography | Device | Endeavor Resolute DES, PRO-Kinetic DES |
| Transthoracic echocardiography CFR measurementCFR will be assessed using transthoracic echocardiography with adenosine infusion. | Device | Endeavor Resolute DES, PRO-Kinetic DES |
Primary outcome
Uncovered stent struts
Time frame: 3 months
Percentage of uncovered stent struts per stent by OCT
Coronary flow reserve
Time frame: 3 months
Coronary flow reserve by transthoracic echocardiography.
1 secondary outcome
MACE and target vessel stent thrombosis
Time frame: 12 months
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 2 Aug 2013.
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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.
Tuomas Kiviniemi, MD, PhD principal investigator
Turku University Hospital
Pasi Karjalainen, MD, PhD principal investigator
Satakunta Central Hospital
Antti Ylitalo, MD, PhD principal investigator
Satakunta Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University of Turku at 2 sites in Finland.
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 8 inclusion and 16 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Uncovered stent struts (time frame: 3 months). 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?
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 2 Aug 2013.