Xience or Vision Stent Management of Angina in the Elderly

NCT02198716 | Completed DMC

• 1 other identifier: Version 2.0 20.06.2008
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary intervention; Elderly; Angina

Outcome Measures

Primary Outcomes (1)

• Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage

  This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage

  1 year

Secondary Outcomes (6)

• Angina status

  1 year

• Antianginal medication

  1 year

• Procedural success

  1 Year

• MACE (major adverse cardiovascular events)

  1 year

• In-hospital complications

  1 Year

Study Arms (2)

Drug eluting stent

OTHER

Percutaneous coronary intervention

Procedure: Percutaneous Coronary Intervention using drug eluting stents

Bare Metal Stent

OTHER

Percutaneous Coronary Intervention

Procedure: Percutaneous Coronary Intervention using bare metal stents

Interventions

Percutaneous Coronary Intervention using drug eluting stents PROCEDURE

Percutaneous Coronary Intervention using drug eluting stents

Also known as: Xience Drug eluting stent

Drug eluting stent

Percutaneous Coronary Intervention using bare metal stents PROCEDURE

Percutaneous Coronary Intervention using bare metal stents

Also known as: Vision BM stent

Bare Metal Stent

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• AGE\>80
• Stable angina or acute coronary syndrome
• Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
• Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
• Any left main stem lesion

You may not qualify if:

• Acute ST segment elevation myocardial infarction
• Cardiogenic shock
• Platelet count =50 x 109/mm3
• Patient life expectancy \< 1 year
• Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
• Recent major GI haemorrhage (within 3 months)
• Any previous cerebral bleeding episode
• Participation in another investigational drug or device study
• Patient unable to give consent
• Clinical decision precluding the use of drug eluting stent

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Cardiac Research Unit

Brighton, Sussex, BN2 1ES, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 24, 2014
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

GB (1)