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

This study has been completed.
Sponsor:
Collaborator:
The Hospital District of Satakunta
Information provided by (Responsible Party):
Tuomas Kiviniemi, University of Turku
ClinicalTrials.gov Identifier:
NCT01391871
First received: July 7, 2011
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Device: OCT
Device: Transthoracic echocardiography CFR measurement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Uncovered stent struts [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Percentage of uncovered stent struts per stent by OCT

  • Coronary flow reserve [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Coronary flow reserve by transthoracic echocardiography.


Secondary Outcome Measures:
  • MACE and target vessel stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Death, MI (Q wave or non-Q wave), emergent CABG, or justified TLR by repeat PCI or CABG, and target vessel stent thrombosis.


Biospecimen Retention:   Samples With DNA

Serum, plasma


Enrollment: 46
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391871

Locations
Finland
Satakunta Central Hospital, Pori
Pori, Finland, 28500
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
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
  More Information

No publications provided

Responsible Party: Tuomas Kiviniemi, MD, PhD, University of Turku
ClinicalTrials.gov Identifier: NCT01391871     History of Changes
Other Study ID Numbers: HAT-TRICK-OCT
Study First Received: July 7, 2011
Last Updated: August 1, 2013
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014