Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2011-06-30
2013-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PRO-Kinetic DES
Patients receiving PRO-Kinetic drug-eluting stent
OCT
Optical coherence tomography
Transthoracic echocardiography CFR measurement
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Endeavor Resolute DES
Patient receiving Endeavor Resolute zotarolimus-eluting stent
OCT
Optical coherence tomography
Transthoracic echocardiography CFR measurement
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Interventions
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OCT
Optical coherence tomography
Transthoracic echocardiography CFR measurement
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
80 Years
ALL
No
Sponsors
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The Hospital District of Satakunta
OTHER
University of Turku
OTHER
Responsible Party
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Tuomas Kiviniemi
MD, PhD
Principal Investigators
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Tuomas Kiviniemi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Pasi Karjalainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Satakunta Central Hospital
Antti Ylitalo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Satakunta Central Hospital
Juhani Airaksinen, MD, PhD, FESC
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Satakunta Central Hospital, Pori
Pori, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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HAT-TRICK-OCT
Identifier Type: -
Identifier Source: org_study_id