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

NCT01201369 | Completed

• 1 other identifier: ORCA-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Coronary Artery Stenosis; Acute Myocardial Infarction; Coronary Artery Stent; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Stent eccentricity index (SEI)

  Immediate post stent deployment during the same angiographic procedure within 60 minutes

• Degree of stent embedding

  Immediate post stent deployment during the same angiographic procedure within 60 minutes

Study Arms (2)

Cypher™ Stent

ACTIVE COMPARATOR

Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent

Device: Coronary Stent Cypher

Xience™ Stent

ACTIVE COMPARATOR

Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA.

Device: Coronary stent Xience

Interventions

Coronary Stent Cypher DEVICE

The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.

Cypher™ Stent

Coronary stent Xience DEVICE

The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols

Xience™ Stent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Harefield Hospital

Harefield, Middlesex, UB96JH, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Miles CD Dalby, MD, MRCP

  Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Robert D Smith, MD, MRCP

  The Royal Brompton & Harefield NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: September 14, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

GB (1)