A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents

Coronary Artery Disease Clinical Trial

— ORCA-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201369
• Other study ID #: ORCA-2
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: July 11, 2011
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Stent Cypher
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
• Coronary stent Xience
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols

Locations

Country	Name	City	State
United Kingdom	Harefield Hospital	Harefield	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No