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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02793349




Registration number
NCT02793349
Ethics application status
Date submitted
3/06/2016
Date registered
8/06/2016

Titles & IDs
Public title
The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study
Scientific title
ABSORB BTK Study: A Prospective, Multi-center, Controlled Clinical Evaluation of the Use of a Bioresorbable Drug Eluting Stent (Absorb, Abbott Vascular) in the Arterial Vasculature Below the Knee
Secondary ID [1] 0 0
HREC 15/051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemia 0 0
Peripheral Arterial Disease (PTA 0 0
Arterial Occlusive Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Absorb Bioresorbable Vascular Scaffold

Experimental: Bioresorbable Vascular Scaffold - Absorb Bioresorbable Vascular Scaffold


Treatment: Devices: Absorb Bioresorbable Vascular Scaffold
Absorb Bioresorbable Vascular Scaffold
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Angiographic patency
Assessment method [1] 0 0
Freedom from angiographic binary in-scaffold restenosis (\>50% stenosis)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Technical success
Assessment method [1] 0 0
Technical success defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.
Timepoint [1] 0 0
Procedure
Secondary outcome [2] 0 0
Haemodynamic primary, assisted primary and secondary patency
Assessment method [2] 0 0
Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
Haemodynamic primary, assisted primary and secondary patency
Assessment method [3] 0 0
Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Haemodynamic primary, assisted primary and secondary patency
Assessment method [4] 0 0
Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Haemodynamic primary, assisted primary and secondary patency
Assessment method [5] 0 0
Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Haemodynamic primary, assisted primary and secondary patency
Assessment method [6] 0 0
Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound
Timepoint [6] 0 0
36 months
Secondary outcome [7] 0 0
Limb salvage rate (LSR)
Assessment method [7] 0 0
Limb salvage defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Target lesion revascularization (TLR)
Assessment method [8] 0 0
Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Rutherford Category
Assessment method [9] 0 0
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Adverse clinical events
Assessment method [10] 0 0
Clinical events defined as fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization
Timepoint [10] 0 0
12 months

Eligibility
Key inclusion criteria
* Stenotic (> 50%) or occlusive atherosclerotic disease of the distal popliteal or infrapopliteal arteries
* A maximum of two focal target lesions in one or more distal popliteal or infrapopliteal vessels
* Length of lesion is maximally 55 mm, allowing maximally 2 stents to be implanted
* Reference vessel diameter should be 2.5 mm-4 mm
* Symptomatic critical limb ischemia (Rutherford 3, 4, 5)
* Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid
* The patient must be > 18 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent that is approved by the ethics committee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patient refusing treatment
* The reference segment diameter is not suitable for available stent design.
* Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis
* Untreatable lesion located at the distal outflow arteries
* More than two infrapopliteal lesions in the same limb
* Previously implanted stent(s) or PTA at the same lesion site
* Lesion location requiring kissing stent procedure
* Lesion lies within or adjacent to an aneurysm
* Inflow-limiting arterial lesions left untreated
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient takes Phenprocoumon (Marcumar).
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is mentally ill or retarded.
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (Cytochrome P450 3A4) (such as Rifampin) within 90 days following the procedure.
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [2] 0 0
Epworth Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
3121 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Delft
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Ramon L Varcoe, MS,FRACS,PhD
Address 0 0
Prince of Wales Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02793349