Clinical trial NCT01776567: Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms
Official title: Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
stents
optical imaging
Lead sponsor: Northern Hospital, Australia
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2013-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: • 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
timeFrame: Immediately following stent deployment
Secondary outcomes:
measure: Percentage of uncovered stent struts
timeFrame: 6 mths post initial PCI procedure
measure: Mean neointimal tissue thickness (microns)
timeFrame: 6 months post initial PCI Procedure
measure: Stent length (mm) measured using OCT
timeFrame: 6 months post initial PCI procedure
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Repatriation Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Epping
country: Australia
facility: Northern Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: Northern Hospital
name: Peter Barlis
role: PRINCIPAL_INVESTIGATOR
References: