Peripheral Vascular DiseasesZilver PTXNCT00120406
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
A study testing Zilver® PTX™ Drug Eluting Vascular Stent and Angioplasty in people with Peripheral Vascular Diseases, run by Cook Group Incorporated at 52 sites in 3 countries.
Trial summary
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Zilver® PTX™ Drug Eluting Vascular Stent and Angioplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 52 sitesin 3 countries
- Study dates
- Mar 2005to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 has signed and dated the informed consent.
- Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
- Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
- Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8.
- Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
Show all 9Show fewer
- Patient agrees to return for x-rays at 6 and 12 months.
- Patient agrees to return for angiography at 12 months.
- Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.
Who cannot join
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient has had previous stenting of target vessel.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
Show all 10Show fewer
- Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
- Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course.
- Patient has untreated angiographically-evident thrombus in the target lesion.
- [Additional criteria may apply.]
Trial locations and contacts
52 sites in 3 countries.
52 sites in 3 countries
United States44 sites
Piedmont Hospital
Atlanta, Georgia, 30309
JFK Memorial Center
Atlantis, Florida, 33462
Bayview Medical Center
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Cleveland Clinic
Cleveland, Ohio, 44195
South Carolina Heart Center
Columbia, South Carolina, 92904
MidWest Cardiology Research Foundation
Columbus, Ohio, 43214
EMH Regional Medical Center
Elyria, Ohio, 44035
Michigan Vascular Research Center
Flint, Michigan, 48507
University of Florida
Gainesville, Florida, 32610
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Pinnacle Health Harrisburg
Harrisburg, Pennsylvania, 17110
Methodist Hospital
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46260
The Care Group
Indianapolis, Indiana, 46290
Memorial -- Jacksonville
Jacksonville, Florida, 32216
St. Luke's Hospital Kansas
Kansas City, Missouri, 64111
Christus St. Patrick Hospital
Lake Charles, Louisiana, 70601
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
St. Luke's Hospital
Milwaukee, Wisconsin, 53215
El Camino Hospital
Mountain View, California, 94040
LDS
Murray, Utah, 84107
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
NYU Medical Center
New York, New York, 10016
St. Luke's Roosevelt Hospital Center
New York, New York, 10025
New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill
New York, New York, 10075
Tri-City Medical Center
Oceanside, California, 92056
Orlando Regional Medical Center
Orlando, Florida, 32806
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont
Royal Oak, Michigan, 48073
Peripheral Vascular Associates (PVA)
San Antonio, Texas, 78229
Prairie Heart
Springfield, Illinois, 62702
Stanford University Hospital and Clinics
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo University Medical Center
Toledo, Ohio, 43614
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany4 sites
Herz-Zentrum
Bad Krozingen, 79189
Gemeinschaftspraxis
Leipzig, 04177
Heart Center Leipzig, Angiology
Leipzig, 04289
Universitatsklinikum Magdeburg
Magdeburg, 39120
Japan4 sites
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Kyoto University Hospital
Kyoto, 606-8507
Nara Medical University
Nara, 634-8522
The Jikei University Hospital
Nishi-Shinbashi, Minato-ku
About this study
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).
Read the detailed description
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery (SFA) and the region of the popliteal artery above the plane of the femoral epicondyles. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the FDA.
This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be captured on paper and electronic case report forms. Analyses will include evaluation of the composite event-free survival rate and the patency rate at 6- and 12-month follow-up. Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be randomized to one or more of the following sub-studies: IVUS and angiography at 6 months (stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX patients only), or ultrasound (PTA patients only). The trial also includes provisions for patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX stent or a bare Zilver stent.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Zilver® PTX™ Drug Eluting Vascular Stent, Angioplasty
- Keywords
- Peripheral Arterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilver® PTX™ Drug Eluting Vascular StentDevice
Stenting of the Superfemoropopliteal Artery
AngioplastyProcedure or surgery
Also called Balloon, PTA
Angioplasty of the Superfemoropopliteal Artery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zilver® PTX™ Drug Eluting Vascular Stent Receives: Device: Zilver® PTX™ Drug Eluting Vascular Stent |
| 2 | Active comparator | Angioplasty Receives: Procedure: Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival Rate
Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
Measured: 12 months
Primary Patency
Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startMar 2005
- Primary completionOct 2009
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- William Cook Europe, MED Institute, Incorporated, Cook Japan Incorporated
- Responsible party
- Sponsor
- Investigators
- Michael Dake, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120406
- Sponsor's protocol ID
- 06-026
- Other IDs
- PS2
- Acronym
- Zilver PTX
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2005
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
PubMed 33025243Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11.
PubMed 26969758Ohki T, Yokoi H, Kichikawa K, Kimura T, Snyder SA, Ragheb AO, O'Leary EE, Jaff MR, Ansel GM, Dake MD. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.
PubMed 25290792Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.
PubMed 23583245Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
PubMed 21953370
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT00120406
- Acronym / sponsor ID
- Zilver PTX / 06-026
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Peripheral Arterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- William Cook Europe, MED Institute, Incorporated, Cook Japan Incorporated
- Study start
- Mar 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Jul 2005 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).
Detailed description
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery (SFA) and the region of the popliteal artery above the plane of the femoral epicondyles. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the FDA.
This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be captured on paper and electronic case report forms. Analyses will include evaluation of the composite event-free survival rate and the patency rate at 6- and 12-month follow-up. Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be randomized to one or more of the following sub-studies: IVUS and angiography at 6 months (stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX patients only), or ultrasound (PTA patients only). The trial also includes provisions for patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX stent or a bare Zilver stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Zilver® PTX™ Drug Eluting Vascular StentZilver® PTX™ Drug Eluting Vascular Stent |
| 2 | Active comparator | Procedure: AngioplastyAngioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has signed and dated the informed consent.
- Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
- Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
- Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8.
Key exclusion criteria (10 listed)
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient has had previous stenting of 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™ Drug Eluting Vascular StentStenting of the Superfemoropopliteal Artery | Device | 1 |
| AngioplastyAlso: Balloon, PTAAngioplasty of the Superfemoropopliteal Artery | Procedure or surgery | 2 |
Primary outcome
Event-free Survival Rate
Time frame: 12 months
Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
Primary Patency
Time frame: 12 months
Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33025243Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
- Derived from this study: PubMed 26969758Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11.
- Derived from this study: PubMed 25290792Ohki T, Yokoi H, Kichikawa K, Kimura T, Snyder SA, Ragheb AO, O'Leary EE, Jaff MR, Ansel GM, Dake MD. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.
- Derived from this study: PubMed 23583245Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.
- Derived from this study: PubMed 21953370Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
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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.
Michael Dake, M.D. principal investigator
Stanford University
52 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zilver® PTX™ Drug Eluting Vascular Stent and Angioplasty in people with Peripheral Vascular Diseases, run by Cook Group Incorporated at 52 sites in 3 countries.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Germany, Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Event-free Survival Rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00120406, which also lists 5 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 11 Aug 2014.