Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000724279
Ethics application status
Approved
Date submitted
20/08/2009
Date registered
24/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions
Scientific title
A Prospective, Multicentre Trial to assess the safety & effectiveness of an
Everolimus-Eluting Coronary Stent System
(PROMUS Element) for the Treatment of a Single De Novo Coronary Artery Long Lesion (24 - 34mm in length)
Universal Trial Number (UTN)
Trial acronym
PLATINUM - LL Subtrial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic lesions in the coronary artery 243494 0
Condition category
Condition code
Cardiovascular 239796 239796 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. One 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 released into the surrounding arterial tissue for approximately 3 months following stent implantation. 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] 237114 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240566 0
12-month target lesion failure (TLF) rate, defined as any ischaemia-driven revascularisation of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Qwave) related to the target vessel, or cardiac death related to the target vessel
Timepoint [1] 240566 0
12 months after intervention
Secondary outcome [1] 257168 0
Target lesion revascularization (TLR)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 quantitative coronary angiography (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.
Timepoint [1] 257168 0
30 days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years & 5 years after intervention
Secondary outcome [2] 257169 0
Target vessel revascularization (TVR) is defined as a 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 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.
Timepoint [2] 257169 0
30 days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years & 5 years after intervention

Eligibility
Key inclusion criteria
1. Patient is eligible for percutaneous coronary intervention (PCI)
2. Patient has documented stable angina
pectoris, or documented silent ischaemia, or
unstable angina pectoris
3. Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG)
4. Patient has left ventricular ejection fraction of >30%
5. Target lesion must be de novo and located within native coronary artery with diameter 2.5mm to 4.25mm
6. Target lesion must be 24mm to 34mm in length
7. Target lesion must be in a major coronaryartery 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 72 hours prior to 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
5. Females who are pregant, nursing/lactating or planning to procreate within 12 months of the index procedure

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2005 0
3065
Recruitment postcode(s) [2] 2039 0
3168
Recruitment outside Australia
Country [1] 1948 0
New Zealand
State/province [1] 1948 0
Country [2] 1949 0
Japan
State/province [2] 1949 0
Country [3] 1950 0
United States of America
State/province [3] 1950 0

Funding & Sponsors
Funding source category [1] 237487 0
Commercial sector/Industry
Name [1] 237487 0
Boston Scientific Corporation
Country [1] 237487 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Pty Ltd
Address
Level 5 247 Coward Street
Mascot
NSW 2020
Country
Australia
Secondary sponsor category [1] 236970 0
Commercial sector/Industry
Name [1] 236970 0
Boston Scientific Corporation
Address [1] 236970 0
100 Boston Scientific Way
Marlborough
MA 01752
Country [1] 236970 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239608 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 239608 0
Ethics committee country [1] 239608 0
Australia
Date submitted for ethics approval [1] 239608 0
11/08/2009
Approval date [1] 239608 0
19/08/2009
Ethics approval number [1] 239608 0

Summary
Brief summary
The PROMUS Element Long Lesion clinical trial –PLATINUM LL, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with a lesion that is 24-34mm in length. Treatment will be in participants with a single de novo (new or untreated) atherosclerotic coronary artery lesion. A separate coronary artery (de novo) narrowing is able to be treated with a
commercial treatment (eg: stent such as
PROMUS, balloon angioplasty, excluding
brachytherapy) during the initial procedure. Up to 35 sites enrolling up to 102 patients.
Follow up at 30 days, 6 and 12 months after intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30039 0
Address 30039 0
Country 30039 0
Phone 30039 0
Fax 30039 0
Email 30039 0
Contact person for public queries
Name 13286 0
Mary Kennell
Address 13286 0
Boston Scientific
Level 5, 247 Coward Street
Mascot
NSW 2020
Country 13286 0
Australia
Phone 13286 0
+612 8063 8144
Fax 13286 0
Email 13286 0
[email protected]
Contact person for scientific queries
Name 4214 0
Ian T Meredith
Address 4214 0
MonashHEART, Southern health
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168
Country 4214 0
Australia
Phone 4214 0
+613 9594 2726
Fax 4214 0
Email 4214 0
[email protected]

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