Vascular Healing of DES at 3 Months

NCT01391871 | Completed

• 1 other identifier: HAT-TRICK-OCT
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• MACE and target vessel stent thrombosis

  12 months

Study Arms (2)

PRO-Kinetic DES

Patients receiving PRO-Kinetic drug-eluting stent

Device: OCT; Device: Transthoracic echocardiography CFR measurement

Endeavor Resolute DES

Patient receiving Endeavor Resolute zotarolimus-eluting stent

Device: OCT; Device: Transthoracic echocardiography CFR measurement

Interventions

OCT DEVICE

Optical coherence tomography

Endeavor Resolute DES; PRO-Kinetic DES

Transthoracic echocardiography CFR measurement DEVICE

CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Endeavor Resolute DES; PRO-Kinetic DES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turku: lead
• The Hospital District of Satakunta: collaborator

Study Sites (2)

Satakunta Central Hospital, Pori

Pori, 28500, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

FI (2)