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)
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.
Peripheral Vascular Disease
Device: Zilver PTX
Device: prosthetic bypass
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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.
- 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 ]
- 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 ]
|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)|
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
|Contact: Bavo Van Puyvelde||+32 52 25 28 firstname.lastname@example.org|
|Aalst, Belgium, 9300|
|Contact: Lieven Maene, MD +32 53 72 46 99 email@example.com|
|Principal Investigator: Lieven Maene, MD|
|Bonheiden, Belgium, 2820|
|Contact: Patrick Peeters, MD firstname.lastname@example.org|
|Principal Investigator: Patrick Peeters, MD|
|Dendermonde, Belgium, 9200|
|Contact: Marc Bosiers, MD +32 52 25 28 22 email@example.com|
|Principal Investigator: Marc Bosiers, MD|
|University Hospital Antwerp||Recruiting|
|Edegem, Belgium, 2650|
|Contact: Jeroen Hendriks, MD +32 821 56 07 firstname.lastname@example.org|
|Principal Investigator: Jeroen Hendriks, MD, PhD|
|RZ Heilig Hart Hospital||Recruiting|
|Tienen, Belgium, 3300|
|Contact: Koen Keirse, MD +32 16 80 99 72 email@example.com|
|Principal Investigator: Koen Keirse, MD|