Peripheral Vascular DiseasePhase 4ZILVERPASSNCT01952457
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
A Phase 4 study testing Zilver PTX and prosthetic bypass in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Zilver PTX and prosthetic bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 5 sitesBelgium
- Study dates
- Aug 2014to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
OLV Hospital
Aalst, 9300
Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, 9200
University Hospital Antwerp
Edegem, 2650
RZ Heilig Hart Hospital
Tienen, 3300
About this study
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.
Read the detailed description
A global noticeable tendency is the increasing prevalence of peripheral artery disease (PAD). Approximately 27 million people in Europe and North America are affected by PAD. Risk factors attaining this high prevalence include age, obesity, nicotine abuse, hypertension, hyperlipidemia, diabetes and family history. PAD can present itself asymptomatically or symptomatically by intermittent claudication (IC) or critical limb ischemia (CLI).
The conservative treatment of PAD comprises of smoking cessation, exercise and management of other risk factors associated with the disease. However, a medical intervention is indicated in those patients presenting with disabling IC, CLI or in cases where conservative treatment does not afford relief.
The Inter-Society Consensus for the Management of PAD (TASC II) published an overview of the different categories of PAD. The TASC II recommendations for the treatment of femoral popliteal lesions are shown in Figure 1. For TASC A \& B lesions, the endovascular treatment is preferred and for TASC C \& D lesions, the surgical treatment is preferred.
The surgical treatment with prosthetic bypasses yielded good results in numerous trials. Berglund, Björck and Elfström (2005) conducted a retrospective study in which 499 patients were assessed. These patients received an above-knee femoropopliteal bypass with a saphenous vein graft (139 subjects) or an ePTFE graft (360 subjects). Primary patency after 12 months was 87% and 75% for the venous bypass and prosthetic bypass respectively. Jensen et al. (2007) investigated 427 patients in a randomized trial with patients who underwent an above-knee femoropopliteal bypass. Eventually, 205 patients received a PTFE bypass graft and 208 received a Dacron bypass graft (14 patients were excluded). The primary patency rates after 12 months were 70% and 78% for PTFE and Dacron respectively. Kedora et al. (2007) compared 86 patients (100 limbs) with femoropopliteal artery occlusive disease in their randomized trial. 50 limbs were treated with angioplasty and one or more self-expanding stent grafts, the other 50 limbs were treated with a synthetic Dacron or ePTFE bypass graft. After 12 months, the primary patency for the bypass group was 74.2%. In a similar study setup, McQuade, Gable, Hohman, Pearl \& Theune (2009) studied 100 limbs in 86 patients with superficial femoral artery occlusive disease. 50 limbs were treated with angioplasty and one or more stent grafts, the other randomized 50 limbs were treated with a synthetic Dacron or ePTFE bypass graft. The bypass arm of this study had a primary patency after 12 months of 77%. A total of 27 patients with TASC D lesions in the superficial femoral artery were analyzed by Hines, Wain, Montecalvo \& Feuerman (2010). All patients received a bypass with an endoscopic saphenous vein. After 12 months the primary patency was 73.2%.
At the LINC congress Bosiers (2012) presented an analysis on 100 surgical primary patent bypasses. Surgical primary patency is measured by assessing flow through the bypass. Endovascular primary patency is measured by the absence of binary restenosis (PSV≥2.4), assessed at the proximal and distal anastomoses. A total of 89% of the surgical primary patent bypasses was evaluated as endovascular patent. This analysis shows a margin of approximately 10% which can be taken into account when interpreting the primary patency of surgical bypasses.
Dake et al. (2011) examined 900 lesions in the superficial and popliteal arteries treated with one or more Zilver PTX drug-eluting stents. The mean lesion length was 99.5 (±82.1) mm and the primary patency after 12 months was 86.2%.
Comparison of the surgical bypass with an endovascular approach in femoropopliteal lesions is been a study set-up that has been used many times. To date, a randomized control between bypass and the new drug-eluting technology as not been conducted. The purpose of this trial is to compare the results of a prosthetic bypass treatment with the Zilver PTX drug-eluting stent treatment. Historical data of the primary patency bypass results, taken the 10% difference between surgical and endovascular patencies into account, gives an endovascular primary patency of approximately 70%. In this non-inferiority trial, the proposed primary patency of the Zilver PTX drug-eluting stent is set at 80% to show that the treatment with a drug-eluting stent is comparable to the treatment with a prosthetic bypass.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Zilver PTX, prosthetic bypass
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilver PTXDevice
prosthetic bypassDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: prosthetic bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startAug 2014
- Primary completionSep 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952457
- Sponsor's protocol ID
- FMRP-121003
- Acronym
- ZILVERPASS
- Status last verified
- Mar 2018
- First submitted
- 10 Sep 2013
- Last updated
- 6 Mar 2018
- Results posted
- No
Publications
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.
PubMed 37162238Bosiers 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.
PubMed 31997715
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01952457
- Acronym / sponsor ID
- ZILVERPASS / FMRP-121003
- Conditions
- Peripheral Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Aug 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A global noticeable tendency is the increasing prevalence of peripheral artery disease (PAD). Approximately 27 million people in Europe and North America are affected by PAD. Risk factors attaining this high prevalence include age, obesity, nicotine abuse, hypertension, hyperlipidemia, diabetes and family history. PAD can present itself asymptomatically or symptomatically by intermittent claudication (IC) or critical limb ischemia (CLI).
The conservative treatment of PAD comprises of smoking cessation, exercise and management of other risk factors associated with the disease. However, a medical intervention is indicated in those patients presenting with disabling IC, CLI or in cases where conservative treatment does not afford relief.
The Inter-Society Consensus for the Management of PAD (TASC II) published an overview of the different categories of PAD. The TASC II recommendations for the treatment of femoral popliteal lesions are shown in Figure 1. For TASC A \& B lesions, the endovascular treatment is preferred and for TASC C \& D lesions, the surgical treatment is preferred.
The surgical treatment with prosthetic bypasses yielded good results in numerous trials. Berglund, Björck and Elfström (2005) conducted a retrospective study in which 499 patients were assessed. These patients received an above-knee femoropopliteal bypass with a saphenous vein graft (139 subjects) or an ePTFE graft (360 subjects). Primary patency after 12 months was 87% and 75% for the venous bypass and prosthetic bypass respectively. Jensen et al. (2007) investigated 427 patients in a randomized trial with patients who underwent an above-knee femoropopliteal bypass. Eventually, 205 patients received a PTFE bypass graft and 208 received a Dacron bypass graft (14 patients were excluded). The primary patency rates after 12 months were 70% and 78% for PTFE and Dacron respectively. Kedora et al. (2007) compared 86 patients (100 limbs) with femoropopliteal artery occlusive disease in their randomized trial. 50 limbs were treated with angioplasty and one or more self-expanding stent grafts, the other 50 limbs were treated with a synthetic Dacron or ePTFE bypass graft. After 12 months, the primary patency for the bypass group was 74.2%. In a similar study setup, McQuade, Gable, Hohman, Pearl \& Theune (2009) studied 100 limbs in 86 patients with superficial femoral artery occlusive disease. 50 limbs were treated with angioplasty and one or more stent grafts, the other randomized 50 limbs were treated with a synthetic Dacron or ePTFE bypass graft. The bypass arm of this study had a primary patency after 12 months of 77%. A total of 27 patients with TASC D lesions in the superficial femoral artery were analyzed by Hines, Wain, Montecalvo \& Feuerman (2010). All patients received a bypass with an endoscopic saphenous vein. After 12 months the primary patency was 73.2%.
At the LINC congress Bosiers (2012) presented an analysis on 100 surgical primary patent bypasses. Surgical primary patency is measured by assessing flow through the bypass. Endovascular primary patency is measured by the absence of binary restenosis (PSV≥2.4), assessed at the proximal and distal anastomoses. A total of 89% of the surgical primary patent bypasses was evaluated as endovascular patent. This analysis shows a margin of approximately 10% which can be taken into account when interpreting the primary patency of surgical bypasses.
Dake et al. (2011) examined 900 lesions in the superficial and popliteal arteries treated with one or more Zilver PTX drug-eluting stents. The mean lesion length was 99.5 (±82.1) mm and the primary patency after 12 months was 86.2%.
Comparison of the surgical bypass with an endovascular approach in femoropopliteal lesions is been a study set-up that has been used many times. To date, a randomized control between bypass and the new drug-eluting technology as not been conducted. The purpose of this trial is to compare the results of a prosthetic bypass treatment with the Zilver PTX drug-eluting stent treatment. Historical data of the primary patency bypass results, taken the 10% difference between surgical and endovascular patencies into account, gives an endovascular primary patency of approximately 70%. In this non-inferiority trial, the proposed primary patency of the Zilver PTX drug-eluting stent is set at 80% to show that the treatment with a drug-eluting stent is comparable to the treatment with a prosthetic bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zilver PTX | Experimental | Device: Zilver PTXPatients 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. |
| prosthetic bypass | Active comparator | Device: prosthetic bypassPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zilver PTX | Device | Zilver PTX |
| prosthetic bypass | Device | prosthetic bypass |
Primary outcome
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.
1 secondary outcome
Proportion of subjects who experience device malfunction or serious device-related or serious adverse events within 30 days post-procedure
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 37162238Bosiers 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.
- Derived from this study: PubMed 31997715Bosiers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zilver PTX and prosthetic bypass in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.