Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000244303
Ethics application status
Approved
Date submitted
5/05/2008
Date registered
13/05/2008
Date last updated
13/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study
Scientific title
Evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study in patients with superficial femoral artery diseae.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial femoral artery disease 2905 0
Condition category
Condition code
Cardiovascular 3040 3040 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single Flexstent peripheral stent system is implanted in the diseased vessel of the superficial femoral artery using the participating hospital standard procedures.
The stents are intended to remain in the diseased vessel.
Intervention code [1] 2636 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3965 0
Efficacy as measured by in-stent binary restenosis using ultrasound
Timepoint [1] 3965 0
1, 3, 6, 9, and 12 months.
Primary outcome [2] 3966 0
Safety as measured by adverse events
Timepoint [2] 3966 0
1, 3, 6, 9, and 12 months.
Secondary outcome [1] 6666 0
Rutherford measurement (scale representing severity of disease)
Timepoint [1] 6666 0
Pre-treatment, following treatment, 1, 6, and 12 months.
Secondary outcome [2] 7070 0
Ankle brachial index
Timepoint [2] 7070 0
Pre-treatment, after treatment, 1, 6, and 12 months.
Secondary outcome [3] 7071 0
Standard treadmill test
Timepoint [3] 7071 0
Pre-treatment and 6 months
Secondary outcome [4] 7072 0
Walking impairment questionnaire
Timepoint [4] 7072 0
Pre-treatment, 1, 6, and 12 months
Secondary outcome [5] 7073 0
Primary, primary assisted, and secondary patency.
Timepoint [5] 7073 0
1, 6, and 12 months

Eligibility
Key inclusion criteria
1. Subjects, male or female, must be between the ages of 35 to 80 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
2. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
3. Rutherford Classification Category 2-4
4. Single de novo lesion in the superficial femoral artery
5. Disease segment length =100mm
6. >50% diameter stenosis and occlusion
7. Patent ipsilateral iliac artery
8. Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
9. Target reference vessel diameter 3.5-5.5 mm
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Target lesion previously treated with a stent or surgery
2. Rutherford Classification Category 0,1,5 or 6
3. Inability to tolerate antithrombotic or antiplatelet therapies
4. Pregnancy
5. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
6. Serum creatinine >180 mmol/l
7. Myocardial infarction or stroke within 90 days of enrollment
8. Hypercoagulable state
9. Uncontrollable hypertension

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
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 814 0
New Zealand
State/province [1] 814 0

Funding & Sponsors
Funding source category [1] 3202 0
Commercial sector/Industry
Name [1] 3202 0
Flexible Stenting Solutions, Inc
Country [1] 3202 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Flexible Stenting Solutions Inc
Address
23 Christopher Way, Suite 103
Eatontown, NJ 07724
Country
United States of America
Secondary sponsor category [1] 2871 0
Commercial sector/Industry
Name [1] 2871 0
SJM Associates Limited
Address [1] 2871 0
Kuku Road
RD 14
Ashhurst
Country [1] 2871 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5400 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5400 0
Auckland
Ethics committee country [1] 5400 0
New Zealand
Date submitted for ethics approval [1] 5400 0
Approval date [1] 5400 0
17/04/2008
Ethics approval number [1] 5400 0

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

Contacts
Principal investigator
Name 28423 0
Address 28423 0
Country 28423 0
Phone 28423 0
Fax 28423 0
Email 28423 0
Contact person for public queries
Name 11580 0
Dr Stuart McLachlan
Address 11580 0
Kuku Road
RD 14
Ashhurst
Country 11580 0
New Zealand
Phone 11580 0
+64 6 329-4846
Fax 11580 0
Email 11580 0
[email protected]
Contact person for scientific queries
Name 2508 0
Janet Burpee
Address 2508 0
Flexible Stenting Solutions Inc.
23 Christopher Way, Suite 103
Eatontown, NJ 07724
Country 2508 0
United States of America
Phone 2508 0
+1 732 578-0060
Fax 2508 0
Email 2508 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.