Vascular Healing of DES at 3 Months

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: OCT; Device: Transthoracic echocardiography CFR measurement

• Registration Number: NCT01391871
• Lead Sponsor: University of Turku

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endeavor Resolute DES	Transthoracic echocardiography CFR measurement	Patient receiving Endeavor Resolute zotarolimus-eluting stent
PRO-Kinetic DES	OCT	Patients receiving PRO-Kinetic drug-eluting stent
PRO-Kinetic DES	Transthoracic echocardiography CFR measurement	Patients receiving PRO-Kinetic drug-eluting stent
Endeavor Resolute DES	OCT	Patient receiving Endeavor Resolute zotarolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
Uncovered stent struts	3 months	Percentage of uncovered stent struts per stent by OCT
Coronary flow reserve	3 months	Coronary flow reserve by transthoracic echocardiography.

Secondary Outcome Measures

Name	Time	Method
MACE and target vessel stent thrombosis	12 months	Death, MI (Q wave or non-Q wave), emergent CABG, or justified TLR by repeat PCI or CABG, and target vessel stent thrombosis.

Trial Locations

Locations (2)

Satakunta Central Hospital, Pori; 🇫🇮 Pori, Finland

Turku University Hospital; 🇫🇮 Turku, Finland