Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms

Coronary Artery Disease Clinical Trial

— APPOSE  

Official title:

Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01776567
• Other study ID #: 01/12
• Status: Recruiting
• Phase: Phase 4
• First received: August 11, 2012
• Last updated: August 2, 2014
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2014
• Source: Northern Hospital, Australia
• Contact: Peter Barlis, MBBS MPH PHD FESC FRACP
• Phone: +61 3 8405 8554
• Email: pbarlis[@]unimelb.edu.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.

Hypotheses:

1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.

2. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction

3. Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents

4. No limitation to the number of treated lesions or number of vessels according to the randomization group

5. De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length

Exclusion Criteria:

1. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material

2. Acute ST-segment elevation myocardial infarction

3. Type A lesion including vessel angulation <45 degrees

4. Bypass graft

5. Inability to provide informed consent

6. Pregnancy

7. Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period

8. Left ventricular ejection fraction < 25%

9. Serum creatinine > 180mmol/L

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Everolimus eluting stents

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Concord Repatriation Hospital	Concord	New South Wales
Australia	Northern Hospital	Epping	Victoria
Australia	St Vincent's Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Northern Hospital, Australia	Abbott Vascular

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation		Immediately following stent deployment	No
Secondary	Percentage of uncovered stent struts		6 mths post initial PCI procedure	No
Secondary	Mean neointimal tissue thickness (microns)		6 months post initial PCI Procedure	No
Secondary	Stent length (mm) measured using OCT		6 months post initial PCI procedure	No