Condition category
Circulatory System
Date applied
18/01/2008
Date assigned
07/05/2009
Last edited
12/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Johannes Lammer

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

VIASTAR

Study hypothesis

In 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

Ethics Committee of the Medical University of Vienna approved on the 26th September 2007 (ref: EK Nr 203/2007)

Study design

Randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please email johanna.moyses@akhwien.at to request a patient information sheet

Condition

Peripheral arterial occlusive disease

Intervention

Percutaneous transluminal stenting with GORE VIABAHN® endoprosthesis with Propaten bioactive surface vs bare nitinol stent"

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 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 measures

1. 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 trial start date

01/04/2009

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. 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

Recruitment start date

01/04/2009

Recruitment end date

01/04/2012

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

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

Sponsor type

University/education

Website

http://www.meduniwien.ac.at

Funders

Funder type

Hospital/treatment centre

Funder name

Medical University of Vienna (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vienna General Hospital (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25472936
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23831445

Publication citations

  1. Results

    Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Ristl R, Schoder M, Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease)., J. Am. Coll. Cardiol., 2013, 62, 15, 1320-1327, doi: 10.1016/j.jacc.2013.05.079.

Additional files

Editorial Notes

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