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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776567

Acronym

APPOSE

Enrollment

Registered

2013-01-28

Start date

2012-07-31

Completion date

2015-06-30

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, stents, optical imaging

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.

Interventions

DEVICEEverolimus eluting stents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
• 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

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

Countries

Australia

Contacts

Primary ContactPeter Barlis, MBBS MPH PHD FESC FRACP

pbarlis@unimelb.edu.au+61 3 8405 8554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026