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Trial registered on ANZCTR


Registration number
ACTRN12611000897965
Ethics application status
Approved
Date submitted
21/07/2011
Date registered
23/08/2011
Date last updated
23/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Tetherx Natural Vascular Scaffolding (NVS) Procedure for Treating Patients with Atherosclerosis of the Femoropopliteal Artery
Scientific title
This is a prospective, single-center, first-in-man, proof-of-concept study to be conducted at Auckland City Hospital, Auckland, New Zealand to evaluate the safety and performance of the Tetherx NVS System in subjects with femoropopliteal atherosclerosis, Rutherford category 2-4.
Secondary ID [1] 262677 0
Nil
Universal Trial Number (UTN)
U1111-1123-0317
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of claudication or ischemic rest pain (Rutherford category 2, 3, or 4) with suspected atherosclerosis in either the superficial femoral artery or the proximal popliteal artery (above the knee articulation). 268380 0
Condition category
Condition code
Cardiovascular 268517 268517 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of the NVS balloon catheter in clinical practice is the same as other percutaneous transluminal angioplasty (PTA) balloon catheters used to perform balloon angioplasty.

The steps of the NVS procedure include:

1) Inflate both occlusion balloons so that the treatment zone (length of the artery between both occlusion balloons) is isolated. Keep the occlusion balloons inflated for the duration of the procedure.

2) Inject the NVS Solution - which is a polyethylene-glycol (PEG)-based, aqueous solution - in between the 2 inflated occlusion balloons. This will enable the NVS solution to diffuse into the vessel wall. The duration to let the NVS Solution diffuse into the vessel wall is 5 minutes.

3) Inflate the balloon in between the 2 occlusion balloons; this is the Treatment Zone Balloon. Keep the Treatment Zone Balloon inflated for the duration of the light activation (see step below - i.e. 60 seconds).

4) Activate the light fiber that runs through the catheter so that blue light (light with wavelength of 444-457nm) activates the NVS Solution; the duration to activate the light fiber is 60 seconds.

Note that the lumen in the catheter that the light fiber is in has a saline drip attached to it which enables a constant flow of saline to mitigate any risk of heat transferring from the light fiber to the catheter lumen, balloon or vessel.

5) Deflate the Occlusion Balloons and the Treatment Zone Balloons and remove the NVS Delivery Catheter.

The NVS Treatment is now complete. The duration of the procedure is between 8-10 minutes.
Intervention code [1] 267018 0
Treatment: Devices
Comparator / control treatment
- The method and tecnique for inflating the Occlusion Balloons is similar to inflating a percutaneous transluminal angioplasty (PTA) balloon; this includes inflating the balloon with a mixture of contrast media and saline such that the inflated balloon can be verified angiographically. The duration of inflation is 8-10 minutes; this is longer than the 3-5 minutes that a PTA balloon is inflated for

- The method and technique for inflating the Treatment Zone Balloon - is the same as stated above for the Occlusion Balloons; the duration that the Treatment Zone Balloon is inflated for (60 seconds) is less than the inflation time for a PTA balloon (3-5 minutes).

- The method and technique for injecting the NVS Solution is the same as injecting contrast media and saline through the catheter; e.g. a 5cc or 10cc syringe is used to do so.

- The method and technique for activating the light fiber includes turning on the blue light source that the light fiber is attached to; after 60 seconds, the blue light source is turned off

- The method and technique for providing a cooling flush though the catheter lumen that the light fiber is in includes attaching the tubing that extends from a saline bag to the catheter itself.

The Historical control group is sourced from a peer-review scientific journal (Catheterization and Cardiovascular Interventions) from 2007, Volume 69, pages 910-919.
Control group
Historical

Outcomes
Primary outcome [1] 269263 0
Safety as determined by either angiographic criteria or duplex ultrasonography criteria in the presence of return of symptoms (an increase in the Rutherford Classification by greater than 1 category) and/or decline in rest Ankle Brachial Indices from the post-procedure baseline value.
Timepoint [1] 269263 0
During the procedure and immediately following the procedure (acute) and 30 days.
Primary outcome [2] 269386 0
Freedom from index limb amputation; method of assessment is clinical assessments.
Timepoint [2] 269386 0
During the procedure and immediately following the procedure (acute) and 30 days.
Primary outcome [3] 269387 0
Freedom from clinically-driven target lesion revascularization (TLR); method of assessment is clinical assessments and Duplex Doppler Ultrasound.
Timepoint [3] 269387 0
During the procedure and immediately following the procedure (acute) and 30 days.
Secondary outcome [1] 279243 0
Efficacy as determined by a Duplex Ultrasound (DUS) Peak systolic velocity ratio (PSVR) and freedom from clinically-driven target lesion revascularization. Clinically-driven is defined as either a PSVR greater than or equal to 2.5 or visually estimated angiographic percent DS greater than 70% and one of the following: an increase in the Rutherford Classification by greater than 1 category from the 30 day post-intervention Rutherford Classification and/or a decline in rest Ankle Brachial Index (ABI) of greater than 0.15 from post-procedure baseline value
Timepoint [1] 279243 0
Post intervention at 30 days, 6 months and 12 months.
Secondary outcome [2] 287526 0
Freedom from clinically-driven target lesion revascularization (TLR). Method of assessment is Duplex Doppler Ultrasound.
Timepoint [2] 287526 0
6 months and 12 months.

Eligibility
Key inclusion criteria
I1 Age > 18 years and < 85 years
I2 Subject or subject’s legal representative have been informed of the nature of the study, agrees to participate and has signed an EC approved consent form
I3 Female subjects of childbearing potential have a negative pregnancy test at 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
I4 Subject understands the duration of the study and its follow up visit requirements
I5 Subject has documented claudication or ischemic rest pain in the target limb prior to the study procedure with documented Rutherford category 2, 3, or 4
I6 Subject is able to walk unassisted
I7 Subject has a documented resting ABI < 0.9 or a toe brachial index (TBI) performed (if ABI non-diagnostic) prior to enrollment
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
I1 Life expectancy < 12 months (in the Investigator’s opinion)
I2 Debilitating cerebrovascular accident (CVA) or ST Segment Myocardial Infarction (STEMI) within the 3 months prior to enrollment
I3 Administration of local systemic thrombolytics for acute limb ischemia (ALI) within the previous 30 days
I4 Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or the NVS vascular polyethylene glycol (PEG) solution
I5 Allergy to contrast media that cannot be adequately pre-treated prior to procedure
I6 Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
I7 Untreatable bleeding diatheses, hypercoagulable state, thrombocytopenia, and/or other bleeding disorder unresponsive to or not improved by blood transfusion
I8 Systemic infection present or suspected
I9 Enrolled in another investigational device, drug, or biologic study in which the subject has not completed the follow-up requirements
I10 There is an additional planned percutaneous intervention (cardiac/peripheral) < 30 days following the study procedure
I11 Subject is breast-feeding or plans to become pregnant during the follow-up period
I12 Previous lower limb amputation, excluding toe amputations

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)
Up to 30 subjects presenting with symptoms of claudication or ischemic rest pain (Rutherford category 2, 3, or 4) with suspected atherosclerosis in either the superficial femoral artery or the proximal popliteal artery (above the knee articulation) will be consented and screened for potential enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will not be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3742 0
New Zealand
State/province [1] 3742 0

Funding & Sponsors
Funding source category [1] 267497 0
Charities/Societies/Foundations
Name [1] 267497 0
Avera Health
Country [1] 267497 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Tetherx, Inc.
Address
41 Darlene Drive
Southborough, MA 01772
Country
United States of America
Secondary sponsor category [1] 268763 0
None
Name [1] 268763 0
None
Address [1] 268763 0
None
Country [1] 268763 0
United States of America
Other collaborator category [1] 252221 0
None
Name [1] 252221 0
None
Address [1] 252221 0
None
Country [1] 252221 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269466 0
Northern X Ethics Committee
Ethics committee address [1] 269466 0
Ethics committee country [1] 269466 0
New Zealand
Date submitted for ethics approval [1] 269466 0
25/03/2011
Approval date [1] 269466 0
18/04/2011
Ethics approval number [1] 269466 0

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

Contacts
Principal investigator
Name 32905 0
Address 32905 0
Country 32905 0
Phone 32905 0
Fax 32905 0
Email 32905 0
Contact person for public queries
Name 16152 0
Chris D. Pierson
Address 16152 0
41 Darlene Drive
Southborough, MA 01772
Country 16152 0
United States of America
Phone 16152 0
1+508 308 7845
Fax 16152 0
1+508 820 0818
Email 16152 0
cpierson@tetherx.com
Contact person for scientific queries
Name 7080 0
Michele Lucey
Address 7080 0
128 Blye Hill Landing
Newbury, NH 03255
Country 7080 0
United States of America
Phone 7080 0
1+603 763 3455
Fax 7080 0
1+603 763 3456
Email 7080 0
lucey_m@msn.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.