Clinical trial NCT01201369: A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents
Official title: Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Coronary Artery Stenosis
Acute Myocardial Infarction
Coronary Artery Stent
Optical Coherence Tomography
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Stent strut malapposition (SSM)
timeFrame: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Secondary outcomes:
measure: Stent eccentricity index (SEI)
timeFrame: Immediate post stent deployment during the same angiographic procedure within 60 minutes
measure: Degree of stent embedding
timeFrame: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
Study officials:
affiliation: Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust
name: Miles CD Dalby, MD, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Brompton & Harefield NHS Foundation Trust
name: Robert D Smith, MD, MRCP
role: STUDY_DIRECTOR
References: