GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease

ISRCTN ISRCTN48164244
DOI https://doi.org/10.1186/ISRCTN48164244
Secondary identifying numbers N/A
Submission date
18/01/2008
Registration date
07/05/2009
Last edited
12/10/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Johannes Lammer
Scientific

Medical University of Vienna
Waehringer Guertel 18-20
Vienna
1090
Austria

Study information

Study designRandomised controlled multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please email johanna.moyses@akhwien.at to request a patient information sheet
Scientific titleGORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease
Study acronymVIASTAR
Study objectivesIn comparison to the use of bare nitinol stents in treating chronic long Superficial Femoral Artery (SFA) lesions, the use of the GORE VIABAHN® endoprosthesis with bioactive propaten surface will result in greater mid- and long-term patency of the treated arterial lesion.
Ethics approval(s)Ethics Committee of the Medical University of Vienna approved on the 26th September 2007 (ref: EK Nr 203/2007)
Health condition(s) or problem(s) studiedPeripheral arterial occlusive disease
InterventionPercutaneous transluminal stenting with GORE VIABAHN® endoprosthesis with Propaten bioactive surface vs bare nitinol stent"
Intervention typeOther
Primary outcome measure1. Efficacy: Primary patency based on color doppler ultrasonography (CDUS) and computed tomographic angiography (CTA) at 1 year post-procedure
2. Safety: Composite of major procedural (30-day) adverse events
Secondary outcome measures1. Primary assisted patency. Timepoints: 12 and 24 months.
2. Secondary patency. Timepoints: 12 and 24 months.
3. Technical success. Timepoints: Immediately after intervention.
4. Target vessel revascularisation. Timepoints: 12 and 24 months.
5. Target lesion revascularisation. Timepoints: 12 and 24 months.
6. Clinical success. Timepoints: 1 month, 6, 12 and 24 months.
7. Primary composite safety and efficacy endpoint. Timepoints: 1 month and 12 months.
8. Change in ankle-brachial index (ABI). Timepoints: 1, 6, 12 and 24 months.
9. Alternate Peak Systolic Velocity Ratios (PSVR of 2.5 or less). Timepoints: 1, 6, 12 and 24 months.
Overall study start date01/04/2009
Completion date01/04/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. Lifestyle-limiting claudication or rest pain (meeting angiographic entry criteria) affecting a lower extremity (Fontaine stages II-IV)
2. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board
3. At least 18 years of age
4. Noninvasive lower extremity arterial studies within 45-days prior to study procedure demonstrating resting Ankle-Brachial Index (ABI) ? 0.8 in the study limb
5. If applicable, staged ipsilateral vascular procedure = 14 days prior to study procedure. ABIs must be completed prior to the study procedure a minimum of 14 days after the staged vascular procedure
6. If applicable, vascular treatment on non-study leg for bilateral claudication = 14 days prior to study procedure demonstrating Fontaine stage I in non-study leg at the time of study procedure. ABIs must be completed prior to the study procedure a minimum of 14-days after treatment on the non-study leg
7. Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
8. Projected life expectancy of greater than three years
9. The ability to comply with protocol follow-up requirements and required testing
10. Angiographic and Lesion Requirements (assessed intraoperatively):
a. Multiple stenoses or occlusions totalling >15 cm with or without heavy calcification or recurrent stenoses or occlusions that need treatment after two endovascular interventions (>50% by visual estimate) located in the region beginning 1 cm below origin of the profunda femoris artery and ending 5 cm above the radiographic knee joint. Prior angioplasty, if applicable on the target lesion, must have been performed = 6 months prior to the study procedure
b. Orifice and proximal 1 cm of SFA are patent
c. Popliteal artery is patent 5 cm proximal to the radiographic knee joint line
d. Reference diameter of 4.0–7.5 mm in proximal and distal treatment segments within the SFA
e. Angiographic evidence of a minimum of at least one tibial artery runoff to the ankle that does not require intervention
f. Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel
Key exclusion criteria1. Untreated flow-limiting aortoiliac occlusive disease
2. Any previous stenting or surgery in the target vessel
3. Subjects with arterial lesions requiring treatment with device diameters other than 5, 6, 7, or 8 mm
4. Severe ipsilateral common femoral/profunda disease requiring surgical intervention
5. Femoral or popliteal aneurysm
6. Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger’s disease, vasculitis)
7. Tibial artery disease requiring treatment
8. Prior ipsilateral femoral artery bypass
9. Severe medical comorbidities (untreated Coronary Artery Disease [CAD]/Congestive Heart Failure [CHF], severe Chronic Obstructive Pulmonary Disease [COPD], metastatic malignancy, dementia, etc.) or other medical condition that would preclude post-procedural ambulation
10. Popliteal artery vascular access at any time during procedure
11. Serum creatinine >2.5 mg/dL within 45 days prior to study procedure
12. Major distal amputation (above the transmetatarsal) in the study or non-study limb
13. Septicemia
14. Any previously known coagulation disorder, including hypercoagulability
15. Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion)
16. Contraindication to anticoagulation or antiplatelet therapy
17. Known allergies to stent/stent-graft components
18. History of prior life-threatening reaction to contrast agent
19. Currently participating in another clinical research trial
Date of first enrolment01/04/2009
Date of final enrolment01/04/2012

Locations

Countries of recruitment

  • Austria
  • Germany

Study participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Medical University of Vienna (Austria)
University/education

c/o Prof. Dr. Johannes Lammer
Waehringer Guertel 18-20
Vienna
1090
Austria

http://www.meduniwien.ac.at
ROR logo https://ror.org/05n3x4p02

Funders

Funder type

Hospital/treatment centre

Medical University of Vienna (Austria)

No information available

Vienna General Hospital (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/10/2013 Yes No
Results article results 01/02/2015 Yes No

Editorial Notes

12/10/2015: Publication reference added to trial record.

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