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)
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|ClinicalTrials.gov Identifier: NCT01952457|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Device: Zilver PTX Device: prosthetic bypass||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2019|
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
- Primary patency at 12 months [ Time Frame: 12 months ]
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 ]
- Technical success [ Time Frame: 1 day post-op ]
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 ]
- Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ]
- Primary assisted patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ]
- Secondary patency rate at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ]
- Target lesion revascularization at 1, 6, 12, 24-month follow-up [ Time Frame: 1, 6, 12 and 24 months ]
- Clinical success at follow-up [ Time Frame: 1 day and 1, 6, 12 and 24 months ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952457
|Aalst, Belgium, 9300|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|University Hospital Antwerp|
|Edegem, Belgium, 2650|
|RZ Heilig Hart Hospital|
|Tienen, Belgium, 3300|