Vascular Healing of DES at 3 Months (HAT-TRICK-OCT)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: OCT; Device: Transthoracic echocardiography CFR measurement

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Finland
  • Pori, Finland, 28500
    • Satakunta Central Hospital, Pori
  • Turku, Finland, 20520
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndrome treated with PRO-Kinetic DES or Endeavor Resolute DES during index PCI.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRO-Kinetic DES; Patients receiving PRO-Kinetic drug-eluting stent	Device: OCT; Optical coherence tomography; Device: Transthoracic echocardiography CFR measurement; CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Endeavor Resolute DES; Patient receiving Endeavor Resolute zotarolimus-eluting stent	Device: OCT; Optical coherence tomography; Device: Transthoracic echocardiography CFR measurement; CFR will be assessed using transthoracic echocardiography with adenosine infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncovered stent struts	Percentage of uncovered stent struts per stent by OCT	3 months
Coronary flow reserve	Coronary flow reserve by transthoracic echocardiography.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: The Hospital District of Satakunta
• Investigators: Principal Investigator: Tuomas Kiviniemi, MD, PhD, Turku University Hospital; Principal Investigator: Pasi Karjalainen, MD, PhD, Satakunta Central Hospital; Principal Investigator: Antti Ylitalo, MD, PhD, Satakunta Central Hospital; Principal Investigator: Juhani Airaksinen, MD, PhD, FESC, Turku University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: HAT-TRICK-OCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No