The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery for the Treatment The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery of Femoropopliteal TASC C&D Lesions (ZILVERPASS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Flanders Medical Research Program
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01952457
First received: September 10, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

The objective of this clinical investigation is to evaluate the early and mid-term outcome (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C&D femoropopliteal lesions.


Condition Intervention Phase
Peripheral Vascular Disease
Device: Zilver PTX
Device: prosthetic bypass
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • Primary patency at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    defined for the Zilver PTX stent arm as absence of evidence of binary restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio <2.4, and without clinically driven target lesion revascularization (TLR) within 12 months;

    defined for the bypass arm as absence of evidence of binary restenosis or occlusion at the proximal and distal anastomoses and over the entire length of the bypass graft, and without clinically driven reintervention to restore flow in the bypass.



Secondary Outcome Measures:
  • Proportion of subjects who experience device malfunction or serious device-related or serious adverse events within 30 days post-procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Technical success [ Time Frame: 1 day post-op ] [ Designated as safety issue: Yes ]

    For the Zilver PTX stent arm, technical success is defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.

    For the bypass arm, technical success is defined as no graft lesion and a low resistance blood flow pattern in the distal graft and outflow artery, as evidenced by duplex.


  • Infection rate / hematoma at puncture site or at incision sites requiring intervention [ Time Frame: 1 day post-op ] [ Designated as safety issue: Yes ]
  • Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Primary assisted patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Secondary patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Clinical success at follow-up [ Time Frame: 1 day and 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    defined as an improvement of Rutherford classification at 1 day and 1, 6, 12, 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

  • Serious Adverse Events [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zilver PTX
Patients in the Zilver PTX arm have to be treated by placement of the Zilver PTX drug-eluting stent (Cook), according to standard procedures based on the Instructions for Use. The only pre-treatment allowed prior to placement of the Zilver PTX drug-eluting stent (Cook) is standard PTA. Diameter measurements must be performed of the healthy vessel proximal and distal to the previously stented area. Diameter selection of the Zilver PTX drug-eluting stent (Cook) should result in minimal oversizing. The target lesion needs to be completely covered by using as few stents possible. Post-dilatation can be performed according to the Instructions of Use.
Device: Zilver PTX
Active Comparator: prosthetic bypass
Patients in the bypass arm have to be treated with a prosthetic bypass graft according to the institution's standard of care and the Instructions for Use of the prosthetic bypass graft.
Device: prosthetic bypass

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)
  • Patient is willing to comply with specified follow-up evaluations at the specified times
  • Patient is >18 years old
  • Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
  • Patient has a projected life-expectancy of at least 24 months
  • Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8
  • Patient is eligible for treatment with the Zilver PTX paclitaxel-eluting stent (Cook) or with surgical bypass placement
  • 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
  • Stenotic or occlusive de novo lesion located in the femoropopliteal arteries, suitable for endovascular therapy and for bypass surgery
  • Total target lesion length is at least 15cm
  • Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area
  • P2 and P3 are patent and there is angiographic evidence of at least one vessel-runoff to the foot, that does not require intervention (<50% stenotic)
  • Target vessel diameter visually estimated to be >4mm and <9mm at the proximal and distal treatment segments within the SFA

Exclusion Criteria:

  • Untreated flow-limiting aortoiliac stenotic disease
  • Any previous surgery and/or endovascular procedure in the target vessel
  • Severe ipsilateral common/deep femoral disease requiring surgical reintervention
  • Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
  • Femoral or popliteal aneurysm located at the target vessel
  • Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • No patent tibial arteries (>50% stenosis)
  • Prior ipsilateral femoral artery bypass
  • Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
  • Serum creatinine >2.5mg/dL within 45 prior to study procedure unless the subject is currently on dialysis
  • Major distal amputation (above the transmetatarsal) in the study or non-study limb
  • Any previously known coagulation disorder, including hypercoagulability
  • Contraindication to anticoagulation or antiplatelet therapy
  • Known allergies to stent or bypass graft components (nickel-titanium, Dacron, ePTFE, etc.)
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
  • Currently participating in another clinical research trial
  • Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
  • Any planned surgical intervention/procedure within 30 days of the study procedure
  • Target lesion access in the Zilver PTX stent arm not performed by transfemoral approach
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952457

Contacts
Contact: Bavo Van Puyvelde +32 52 25 28 22 office@fmrp.be

Locations
Belgium
OLV Hospital Recruiting
Aalst, Belgium, 9300
Contact: Lieven Maene, MD    +32 53 72 46 99    lieven.maene@olvz-aalst.be   
Principal Investigator: Lieven Maene, MD         
Imelda Hospital Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters, MD       patrick.peeters@imelda.be   
Principal Investigator: Patrick Peeters, MD         
AZ Sint-Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers, MD    +32 52 25 28 22    marc.bosiers@telenet.be   
Principal Investigator: Marc Bosiers, MD         
University Hospital Antwerp Recruiting
Edegem, Belgium, 2650
Contact: Jeroen Hendriks, MD    +32 821 56 07    jeroen.hendriks@uza.be   
Principal Investigator: Jeroen Hendriks, MD, PhD         
RZ Heilig Hart Hospital Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse, MD    +32 16 80 99 72    keirsekoen@hotmail.com   
Principal Investigator: Koen Keirse, MD         
Sponsors and Collaborators
Flanders Medical Research Program
  More Information

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01952457     History of Changes
Other Study ID Numbers: FMRP-121003
Study First Received: September 10, 2013
Last Updated: September 30, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 26, 2014