Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000581369
Ethics application status
Approved
Date submitted
5/11/2008
Date registered
19/11/2008
Date last updated
23/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Compilation of acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element Everolimus-Eluting Coronary Stent System in the treatment of patients with a single new or untreated atherosclerotic lesion
Scientific title
A Prospective, Multicentre Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element) in the Treatment of Patients with a single De Novo Atherosclerotic Lesion
Universal Trial Number (UTN)
Trial acronym
PLATINUM QCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic lesions in a coronary artery 3925 0
Condition category
Condition code
Cardiovascular 4118 4118 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. A single stent will be permanently implanted in the patient via use of a catheter inserted into the vasculature. The drug dosage depends on the size of the stent and varies from 57 micrograms (2.25x12mm stent) to 242 micrograms (4.0x38mm stent) and this drug is gradually eluted into the blood stream following implantation of the stent. Stent size is selected by the investigator based on vessel diameter and length. Typically stent diameter is selected to be slightly larger than the vessel diameter (ie a 3.0mm stent would be used to treat a 2.8mm vessel). Typically stent length is selected so that the stent is 2-4mm longer than the lesion length (ie a 28mm stent would be used to treat a 22mm lesion)
Intervention code [1] 3642 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5009 0
Cardiac events at 30 days post index procedure: Myocardial Infarction, Cardiac Death Rate, Target Lesion Failure (TLF)Rate, Target Lesion Revascularisation (TLR) rate & Stent Thrombosis (ST) rate
Timepoint [1] 5009 0
Cardiac events will be assessed during hospitalization and at the 30 day follow up. Any adverse event experienced prior to the 30 day follow up must be reported within 24 hours. Source data regarding the event will be collected and sent to the Clinical Events Commottee (CEC) for adjudication.
Secondary outcome [1] 8456 0
Target vessel failure (TVF) is any ischemia-driven revascularization of the target vessel, Myocardial Infarction (MI) (Q-wave and non Q-wave) related to the target vessel or death related to the target vessel. If it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Any of the component events (TVR, MI or death) must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the Clinical Events Committee (CEC) for adjudication.
Timepoint [1] 8456 0
30 days, 9 months & 12 months post index procedure
Secondary outcome [2] 8457 0
Target vessel revascularization (TVR) is defined as a Target Lesion Revascularisation (TLR) or a TVR remote. Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
* The patient has a positive functional study corresponding to the area served by the target lesion
* The patient has ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia
Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is 50% by QCA and any of the following are present:

* The patient has a positive functional study corresponding to the area served by the target lesion

* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TVR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia.

Any events must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the Clinical Events Committee (CEC) for adjudication.
Timepoint [2] 8457 0
30 days, 9 months & 12 months post index procedure
Secondary outcome [3] 8458 0
Cardiac Death Rate
Timepoint [3] 8458 0
30 days, 9 months & 12 months post index procedure

Eligibility
Key inclusion criteria
1. Patient is eligible for Percutaneous Coronary Intervention (PCI)
2. Patient has doucmented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris
3. Patient is acceptable candidate for CABG
4. Patient has left ventricular ejection fraction 0f >30%
5. Target lesion must be de novo and located within native coronary artery with diameter >2.25mm and <4.25mm
6. Target lesion must be <34mm in length
7. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >50% and <100%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI)
2. Patient has known diagnosis of recent MI (within 30 days of index procedure) and has elevated enzymes at time of index procedure
3. Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure
4. Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1274 0
3168
Recruitment postcode(s) [2] 1275 0
5000
Recruitment postcode(s) [3] 1276 0
4032
Recruitment postcode(s) [4] 1277 0
2050
Recruitment postcode(s) [5] 1278 0
3065
Recruitment postcode(s) [6] 1279 0
2065
Recruitment postcode(s) [7] 1280 0
1871
Recruitment postcode(s) [8] 1281 0
6959
Recruitment postcode(s) [9] 1282 0
6009
Recruitment outside Australia
Country [1] 1347 0
Malaysia
State/province [1] 1347 0
Country [2] 1348 0
Singapore
State/province [2] 1348 0
Country [3] 1349 0
New Zealand
State/province [3] 1349 0

Funding & Sponsors
Funding source category [1] 4106 0
Commercial sector/Industry
Name [1] 4106 0
Boston Scientific Corporation
Country [1] 4106 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
100 Boston Scientific Way
Marlborough
MA 01752
Country
United States of America
Secondary sponsor category [1] 3697 0
None
Name [1] 3697 0
Address [1] 3697 0
Country [1] 3697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6179 0
Ethics committee address [1] 6179 0
Ethics committee country [1] 6179 0
Date submitted for ethics approval [1] 6179 0
24/11/2008
Approval date [1] 6179 0
Ethics approval number [1] 6179 0

Summary
Brief summary
PLATINUM QCA is a prospective, multicenter trial to assess PROMUS Element for the treatment of patients with a maximum of 1 de novo atherosclerotic coronary artery lesion of up to 34 mm in total length (by visual estimate) in native coronary arteries =2.25 mm to =4.25 mm in diameter (by visual estimate). Approximately 100 non-randomized patients at up to 20 sites are proposed to obtain clinical outcomes data for the PROMUS Element stent system. Follow up occurs at 30 days, 9 months and 12 months with both QCA and IVUS assessments at 9 months. The Primary Endpoint is Cardiac events at 30 days post-index procedure (Myocardial infarction (MI, Q-wave and non-Q wave) rate; Cardiac death rate; Target lesion failure (TLF) rate; Target lesion revascularization (TLR) rate; Stent thrombosis (ST) rate (definite or probable by Academic Research Consortium [ARC] definitions) with an efficacy endpoint of 9 month in-stent late loss and post-procedure incomplete apposition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29094 0
Address 29094 0
Country 29094 0
Phone 29094 0
Fax 29094 0
Email 29094 0
Contact person for public queries
Name 12251 0
Mary Kennell
Address 12251 0
Boston Scientific
Level 5, 247 Coward Street
Mascot
NSW 2020
Country 12251 0
Australia
Phone 12251 0
+612 8063 8144
Fax 12251 0
Email 12251 0
[email protected]
Contact person for scientific queries
Name 3179 0
Ian T Meredith
Address 3179 0
MonashHEART, Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country 3179 0
Australia
Phone 3179 0
+61 3 9594 2726
Fax 3179 0
Email 3179 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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