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

NCT ID: NCT01201369

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cypher™ Stent

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

Group Type: ACTIVE_COMPARATOR

Coronary Stent Cypher

Intervention Type: DEVICE

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

Xience™ Stent

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

Group Type: ACTIVE_COMPARATOR

Coronary stent Xience

Intervention Type: DEVICE

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

Interventions

Coronary Stent Cypher

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

Intervention Type: DEVICE

Coronary stent Xience

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Consultant Cardiologist, Royal Brompton & Harefield NHS Foundation Trust

Principal Investigators

Miles CD Dalby, MD, MRCP

Role: PRINCIPAL_INVESTIGATOR

Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust

Robert D Smith, MD, MRCP

Role: STUDY_DIRECTOR

The Royal Brompton & Harefield NHS Foundation Trust

Locations

Harefield Hospital

Harefield, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

ORCA-2

Identifier Type: -

Identifier Source: org_study_id