Popliteal ArteryETAPNCT00712309
Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting
A study testing Lifestent and balloon-angioplasty (PTA) in people with Popliteal Artery, run by Herz-Zentrums Bad Krozingen at 2 sites in Germany.
Trial summary
1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery? Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Popliteal Artery
- What is being tested?
- Lifestent and balloon-angioplasty (PTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2007to Jun 2010
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is at least 21 years old
- The patient or legal representative provided written informed consent
- The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
- The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
- The target lesion located within the popliteal artery has angiographic evidence of stenosis > 70% or occlusion (by visual estimate)
- At least one vessel runoff to the foot
- The patient has no other relevant inflow or outflow stenosis (> 50%), however when needed iliac or femoral intervention may be done during study procedure.
Who cannot join
- The patient is currently participating in a drug or another device study.
- The popliteal artery target lesion has previously been subintimal recanalized
- The patient has a history of bleeding diatheses or coagulopathy
- Female patients that are pregnant
- The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
- The patient is unable to conform to the study protocol follow-up procedures or visits.
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- The patient has a life expectancy of <24 months
- The patient has concomitant renal failure which requires dialysis
- The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media
- The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria:
- The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract
- The popliteal artery target lesion is restenotic
- The popliteal artery has been subintimal recanalized
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Thomas Zeller, MD, 004976334024350, thomas.zeller@herzzentrum.de
Thomas Zeller, MD
- Recruiting
Universitäres Herzzentrum Hamburg
Hamburg, 22527
Hans Krankenberg, MD, 0049408890090
About this study
Official title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting
- Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?
- Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
- Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
- Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
- How do the intervention methods compare in terms of safety/incidence of adverse effects?
- What are the long-term clinical implications of the two treatment methods?
- Conditions
- Popliteal Artery
- Being tested
- Lifestent, balloon-angioplasty (PTA)
- Keywords
- atherosclerotic, lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestentDevice
Stent for endovascular treatment of popliteal artery lesions
balloon-angioplasty (PTA)Device
PTA for endovascular treatment of popliteal artery lesions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Percutaneous transluminal angioplasty (PTA) Receives: Device: balloon-angioplasty (PTA) |
| 2 | Active comparator | Primary stenting Receives: Device: Lifestent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
Measured: 12-month
Secondary outcomes (1)
Primary patency
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2010 (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 Popliteal ArteryStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712309
- Sponsor's protocol ID
- ETAP Protocol 2.0
- Acronym
- ETAP
- Status last verified
- Feb 2009
- First submitted
- 8 Jul 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
PubMed 25775675Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Gissler M, Noory E, Neumann FJ, Zeller T. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation. 2013 Jun 25;127(25):2535-41. doi: 10.1161/CIRCULATIONAHA.113.001849. Epub 2013 May 21.
PubMed 23694965
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting
- ClinicalTrials.gov ID
- NCT00712309
- Acronym / sponsor ID
- ETAP / ETAP Protocol 2.0
- Conditions
- Popliteal Artery
- Keywords
- atherosclerotic, lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Feb 2007
- Primary completion
- Jun 2010 (estimated)
- First posted
- 9 Jul 2008 (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.
- Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?
- Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
- Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
- Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
- How do the intervention methods compare in terms of safety/incidence of adverse effects?
- What are the long-term clinical implications of the two treatment methods?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: balloon-angioplasty (PTA)Percutaneous transluminal angioplasty (PTA) |
| 2 | Active comparator | Device: LifestentPrimary stenting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is at least 21 years old
- The patient or legal representative provided written informed consent
- The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
- The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
- The target lesion located within the popliteal artery has angiographic evidence of stenosis > 70% or occlusion (by visual estimate)
Key exclusion criteria (13 listed)
- The patient is currently participating in a drug or another device study.
- The popliteal artery target lesion has previously been subintimal recanalized
- The patient has a history of bleeding diatheses or coagulopathy
- Female patients that are pregnant
- The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
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 |
|---|---|---|
| LifestentStent for endovascular treatment of popliteal artery lesions | Device | 2 |
| balloon-angioplasty (PTA)PTA for endovascular treatment of popliteal artery lesions | Device | 1 |
Primary outcome
Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
Time frame: 12-month
1 secondary outcome
Primary patency
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
- Derived from this study: PubMed 25775675Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
- Derived from this study: PubMed 23694965Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Gissler M, Noory E, Neumann FJ, Zeller T. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation. 2013 Jun 25;127(25):2535-41. doi: 10.1161/CIRCULATIONAHA.113.001849. Epub 2013 May 21.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestent and balloon-angioplasty (PTA) in people with Popliteal Artery, run by Herz-Zentrums Bad Krozingen at 2 sites in Germany.
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 7 inclusion and 13 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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Zeller, MD (004976334024350, thomas.zeller@herzzentrum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s) (time frame: 12-month). 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 NCT00712309, 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 10 Feb 2009.