Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000801617
Ethics application status
Approved
Date submitted
21/12/2005
Date registered
21/12/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
e-Healing (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth), Genous Bio-engineered R stent, Post Marketing Registry.
Scientific title
e-Healing (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth), Genous Bio-engineered R stent, Post Marketing Registry. The e-Healing registry is a 5000 patients internet based registry. The stent is used for the treatment of a group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions. The objective of this registry is to collect post marketing surveillance data on patients receiving at least one Genous Bio-Engineered R stent.
Universal Trial Number (UTN)
Trial acronym
e-Healing
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 960 0
Condition category
Condition code
Respiratory 1030 1030 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The e-Healing registry is a 5000 patients internet based registry (50 patients will be recruited for one site and 5000 patients will be recurited globally). The Genous Bio-engineered R stent is used for the treatment of a group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions.

The Genous Bio-engineered R stent is a coronary balloon expandable vascular prosthesis.

The primary objective of this registry is to collect post marketing surveillance data on patients receiving at least one Genous Bio-engineered R stent when used according to the Instructions for Use. Specifically, data will be collected in order to assess clinical outcomes and safety of patients out to 12 months post procedure receiving at least one Genous Bio-engineered R stent. In addition, the registry is designed to identify any potential unanticipated adverse device-related effects that may not have been noted prior to market approval, to collect data on procedural practices and demographic characteristics and to determine how these variables effect clinical outcomes. The duration of this Registry is 18 months (from the beginning of patient enrollment to the end of patient follow-up).
Intervention code [1] 807 0
Treatment: Devices
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1380 0
The primary outcome is Target Vessel Failure (TVF)
Timepoint [1] 1380 0
At 12 months
Secondary outcome [1] 2445 0
The secondary outcomes include: procedure success, angiographic success (visual estimate), MACE.
Timepoint [1] 2445 0
At 30 day, 6 and 12 months.
Secondary outcome [2] 2446 0
Device related SAES until 12 months and angiographic stent thrombosis.
Timepoint [2] 2446 0

Eligibility
Key inclusion criteria
A group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions. The Genous stent is suitable for treatment of atherosclerotic or restenotic lesions with a length less than the nominal stent length in coronary arteries having reference vessel diameters of the stent expanded diameter following primary inflation.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA).

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
n/a
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment outside Australia
Country [1] 250 0
Germany
State/province [1] 250 0

Funding & Sponsors
Funding source category [1] 1132 0
Commercial sector/Industry
Name [1] 1132 0
OrbusNeich Medical Pty Ltd
Country [1] 1132 0
Primary sponsor type
Commercial sector/Industry
Name
OrbusNeich Medical Pty Ltd.
Address
Country
Hong Kong
Secondary sponsor category [1] 989 0
None
Name [1] 989 0
n/a
Address [1] 989 0
Country [1] 989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2444 0
Academic Medical Center of Amsterdam
Ethics committee address [1] 2444 0
Ethics committee country [1] 2444 0
Netherlands
Date submitted for ethics approval [1] 2444 0
Approval date [1] 2444 0
Ethics approval number [1] 2444 0
Ethics committee name [2] 2445 0
Florence Nightingale Hospital of Istanbul
Ethics committee address [2] 2445 0
Ethics committee country [2] 2445 0
Turkey
Date submitted for ethics approval [2] 2445 0
Approval date [2] 2445 0
Ethics approval number [2] 2445 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35197 0
Address 35197 0
Country 35197 0
Phone 35197 0
Fax 35197 0
Email 35197 0
Contact person for public queries
Name 9996 0
Dr David Eccleston
Address 9996 0
Melbourne Health
The Royal Melbourne Hospital
City Campus
Grattan Street
Parkville VIC 3050
Country 9996 0
Australia
Phone 9996 0
+61 3 93495333
Fax 9996 0
+61 3 93476760
Email 9996 0
[email protected]
Contact person for scientific queries
Name 924 0
Professor Dr. med. Sigmund Silber
Address 924 0
Ludwig-Maximilians University
Dr. Muller Hospital
81379 Munich
Country 924 0
Germany
Phone 924 0
+49 89 74215130
Fax 924 0
+49 89 74215131
Email 924 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

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

Documents added automatically
No additional documents have been identified.