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

NCT01952457 | Unknown Phase 4

• 1 other identifier: FMRP-121003
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency at 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.

  12 months

Secondary Outcomes (1)

• Proportion of subjects who experience device malfunction or serious device-related or serious adverse events within 30 days post-procedure

  30 days

Other Outcomes (8)

• Technical success

  1 day post-op

• Infection rate / hematoma at puncture site or at incision sites requiring intervention

  1 day post-op

• Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up

  1, 6, 12 and 24 months

Study Arms (2)

Zilver PTX

EXPERIMENTAL

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

prosthetic bypass

ACTIVE COMPARATOR

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

Interventions

Zilver PTX DEVICE

Zilver PTX

prosthetic bypass DEVICE

prosthetic bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

Location

Related Publications (2)

• Bosiers M, DE Donato G, Torsello G, Galvagni Silveira P, Deloose K, Scheinert D, Veroux P, Hendriks J, Maene L, Keirse K, Navarro T, Callaert J, Eckstein HH, Tessarek J, Giaquinta A, van den Eynde W, Verbist J, Wahl-Gravsen J, Bosiers MJ. ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis. J Cardiovasc Surg (Torino). 2023 Aug;64(4):413-421. doi: 10.23736/S0021-9509.23.12607-3. Epub 2023 May 10.

  PMID: 37162238 DERIVED

• Bosiers M, Setacci C, De Donato G, Torsello G, Silveira PG, Deloose K, Scheinert D, Veroux P, Hendriks J, Maene L, Keirse K, Navarro T, Callaert J, Eckstein HH, Tebetaarek J, Giaquinta A, Wauters J. ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions. J Endovasc Ther. 2020 Apr;27(2):287-295. doi: 10.1177/1526602820902014. Epub 2020 Jan 30.

  PMID: 31997715 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 30, 2013
• Study Start: August 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

BE (5)