A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents (ORCA-2)

Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study

Despite recent advances in stent technology and clot reducing drug therapy, acute stent occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown that certain features of how the stent relates to the artery wall may predict ST. One such feature, so-called stent strut malapposition (SSM), can be assessed after implantation but current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a newer technology that can be performed safely and easily after angioplasty and may allow the stent struts to be assessed more accurately and reliably.

This study will use OCT to examine how two different types of commonly used drug-eluting stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore that the potentially more pliable structure of the Xience V stent will be associated with greater contact with the vessel wall. This may have a bearing on the relative rate of SSM, although large studies have shown the rate to be low in both the Cypher and the Xience V stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after angioplasty will compliment conventional visual assessment and may identify those patients in whom further improvement of stent with a balloon is necessary.

This study will involve the random allocation of forty patients requiring coronary angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the usual manner as indicated clinically and will include imaging of the stented artery segment with OCT once the operator is satisfied with the visual result by angiography.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coronary Stent Cypher; Device: Coronary stent Xience

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harefield, Middlesex, United Kingdom, UB96JH
      • Harefield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (PCI).
• Eligibility for drug eluting stent (DES) deployment.
• Stable or unstable coronary syndrome presentation, including ST elevation myocardial infarction (STEMI).
• Aged 18-90

Exclusion Criteria:

• Contraindication to the use of a DES.
• Target lesion located within previous stent (in stent restenosis).
• Sustained haemodynamic instability following stent deployment (Systolic BP 90≤ mmHg or sustained ventricular arrhythmia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cypher™ Stent; Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent	Device: Coronary Stent Cypher; The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
Active Comparator: Xience™ Stent; Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA.	Device: Coronary stent Xience; The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent strut malapposition (SSM)	SSM will be quoted as the percentage of malapposed stent struts as a proportion of the total number of struts analysed within each stent group.	Immediate post stent deployment during the same angiographic procedure within 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent eccentricity index (SEI)	This is a commonly used measure that is designed to quantify the uniformity and symmetry of the stent after it has been deployed in the coronary artery. It is calculated as the minimum diameter of the stent divided by the maximum diameter of the stent at a preset point. The mean SEI will be compared between two stent type groups.	Immediate post stent deployment during the same angiographic procedure within 60 minutes
Degree of stent embedding	This relates to what degree, if at all, the stent strut is 'buried' within the coronary artery wall. The proportion of each strut that is buried or embedded will be calculated and then averaged for each stent group. A strut that is buried in the vessel wall for more than half its thickness will be defined as 'embedded'.	Immediate post stent deployment during the same angiographic procedure within 60 minutes

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Miles CD Dalby, MD, MRCP, Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust; Study Director: Robert D Smith, MD, MRCP, The Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Percutaneous Coronary Intervention; Optical Coherence Tomography; Coronary Artery Stenosis; Coronary Artery Stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ORCA-2