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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Everolimus eluting stents

• Registration Number: NCT01776567
• Lead Sponsor: Northern Hospital, Australia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-11
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-02
• Last Update Posted: 2014-08-05
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cobalt Chromium Everolimus-eluting stent (Xience Prime)	Everolimus eluting stents	Cobalt Chromium Everolimus-eluting stent (Xience Prime)
Platinum Chromium Everolimus-eluting stent (Promus Element)	Everolimus eluting stents	Platinum Chromium Everolimus-eluting stent (Promus Element)

Primary Outcome Measures

Name	Time	Method
• 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

Secondary Outcome Measures

Name	Time	Method
Mean neointimal tissue thickness (microns)	6 months post initial PCI Procedure
Percentage of uncovered stent struts	6 mths post initial PCI procedure
Stent length (mm) measured using OCT	6 months post initial PCI procedure

Trial Locations

Locations (4)

Concord Repatriation Hospital; 🇦🇺 Concord, New South Wales, Australia

The Prince Charles Hospital; 🇦🇺 Brisbane, Queensland, Australia

Northern Hospital; 🇦🇺 Epping, Victoria, Australia

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia