Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000373370
Ethics application status
Approved
Date submitted
12/07/2008
Date registered
31/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study With the IDEAL TM Bioabsorbable Coronary Stent Platform Eluting Sirolimus (WHISPER)
Scientific title
A Pilot Study Evaluating the Safety and Performance of the IDEAL TM Bioabsorbable Coronary Stent Platform Eluting Sirolimus for the Treatment of Patients with Coronary Artery Disease
Universal Trial Number (UTN)
Trial acronym
WHISPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 3404 0
Condition category
Condition code
Cardiovascular 3551 3551 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IDEAL TM Coronary Stent is a biodegradable, drug eluting coronary stent that is implanted through a small incision in the groin area using standard interventional technique (as is done for the placement of any coronary stent) for minimally invasive cardiovascular procedures. Patients who present with a lesion amenable to stent placement and meet the protocol's eligibility criteria may be enrolled and undergo placement of one IDEAL stent.
Intervention code [1] 3127 0
Treatment: Devices
Comparator / control treatment
N/A
Control group
Historical

Outcomes
Primary outcome [1] 4454 0
The primary endpoint is ischemia-driven Target Lesion Failure. Target Lesion Failure is when the lesion requires repeat treatment or results in a myocardial infarction (MI). Ischemia driven means that the repeat intervention is the result of known ischemia. This data will be extracted from the master study database using a statistical analysis software (SAS) or similar and analyzed by a qualified statistician.
Timepoint [1] 4454 0
Target Lesion Failure to 6 months post implant.
Secondary outcome [1] 7524 0
Ischemia-driven Major Adverse Cardiac Events (MACE) measured by
Ischemia-driven Target Vessel Failure (TVF)
ID-Target Lesion Revascularization (ID-TLR) and ID-Target Vessel Revascularization (ID-TVR)
Acute success (device and clinical procedure )
Stent thrombosis (Definite or probable per the Academic Research Consortium (ARC) definition )
Timepoint [1] 7524 0
This outcome will be assessed at 30 days, 6 months, 12 months and 24 months.

Eligibility
Key inclusion criteria
1. The patient has documented evidence of ischemic heart disease or a positive functional study.
2. The patient has a single de novo target lesion in a native coronary artery.
4. Target lesion stenosis is greater than 50% and less than 100%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has a restenotic target lesion.
2. The patient has a lesion involving a bifurcation > 2mm in diameter and ostial lesion > 40% stenosis or side branch requiring dilatation.
3. Target vessel contains visible thrombus.
4. The patient has an inability to tolerate, adverse reaction, or contraindication to taking study medications or device materials.
5. The target lesion is a total occlusion.
6. Myocardial Infarction (MI) within 48 hours.
7. The patient has more than one lesion requiring treatment in the target vessel.
8. The patient has one or more non-target lesion requiring treatment.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1039 0
New Zealand
State/province [1] 1039 0

Funding & Sponsors
Funding source category [1] 3586 0
Commercial sector/Industry
Name [1] 3586 0
Bioabsorbable Therapuetics, LTD
Country [1] 3586 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Bioabsorbable Therapuetics, LTD
Address
Level 11 Petherick Tower, 38-42 Waring Taylor Street
The Terrace, Wellington
Country
New Zealand
Secondary sponsor category [1] 3223 0
None
Name [1] 3223 0
Address [1] 3223 0
Country [1] 3223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5632 0
IRB-ZNA-OCMW Antwerpen
Ethics committee address [1] 5632 0
Commissie voor Medische Ethiek
ZNA Middleheim, Lindendreef 1, 2020, Antwerpen
Ethics committee country [1] 5632 0
Belgium
Date submitted for ethics approval [1] 5632 0
Approval date [1] 5632 0
09/01/2008
Ethics approval number [1] 5632 0

Summary
Brief summary
This study is being performed to evaluate the safety and performance of the IDEAL Stent for the treatment of patients with cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28745 0
Address 28745 0
Country 28745 0
Phone 28745 0
Fax 28745 0
Email 28745 0
Contact person for public queries
Name 11902 0
Pat Rivelli
Address 11902 0
Level 11 Petherick Tower, 38-42 Waring Taylor Street
The Terrace, Wellington
Country 11902 0
United States of America
Phone 11902 0
650-617-0740
Fax 11902 0
Email 11902 0
www.bioabsorbabletx.com
Contact person for scientific queries
Name 2830 0
Pat Rivelli
Address 2830 0
Level 11 Petherick Tower, 38-42 Waring Taylor Street
The Terrace, Wellington
Country 2830 0
United States of America
Phone 2830 0
650-617-0740
Fax 2830 0
Email 2830 0
www.bioabsorbabletx.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.