Vascular Healing of DES at 3 Months

Acute Coronary Syndrome Clinical Trial

— HAT-TRICK-OCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391871
• Other study ID #: HAT-TRICK-OCT
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: August 1, 2013
• Start date: June 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• OCT
Optical coherence tomography
• Transthoracic echocardiography CFR measurement
CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital, Pori	Pori
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncovered stent struts	Percentage of uncovered stent struts per stent by OCT	3 months	Yes
Primary	Coronary flow reserve	Coronary flow reserve by transthoracic echocardiography.	3 months	Yes
Secondary	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	No