Arterial Occlusive DiseasesPhase 4YUKON-BTKNCT00664963
YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study
A Phase 4 study testing Implantation of YUKON Sirolimus-eluting Stent and Implantation of YUKON Stent (uncoated) in people with Arterial Occlusive Diseases, run by Herz-Zentrums Bad Krozingen at 3 sites in Germany.
Trial summary
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Implantation of YUKON Sirolimus-eluting Stent and Implantation of YUKON Stent (uncoated)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2006to Apr 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
- De-novo stenosis of > 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
- Target lesion length of ≤ 45 mm
Who cannot join
- Coagulation disorder
- Known allergy to contrast medium
- Contraindications to antiplatelet therapy or heparin
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Herz-Zentrums Bad Krozingen
Bad Krozingen, 79189
Universitäres Herzzentrum Hamburg
Hamburg, 22527
University Hospital of Tübingen
Tübingen, 72076
About this study
Official title: YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.
Read the detailed description
Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Implantation of YUKON Sirolimus-eluting Stent, Implantation of YUKON Stent (uncoated)
- Keywords
- Arterial Occlusive Diseases, Peripheral Vascular Diseases, Drug eluting stent, Restenosis, Below the knee, Intervention
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of YUKON Sirolimus-eluting StentDevice
Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Stent (uncoated)Device
Implantation of YUKON Stent (uncoated)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | YUKON Sirolimus-eluting Stent Receives: Device: Implantation of YUKON Sirolimus-eluting Stent |
| 2 | Active comparator | YUKON Stent (uncoated) Receives: Device: Implantation of YUKON Stent (uncoated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
Measured: 12 months
Secondary outcomes (1)
Number of reinterventions of target vessel
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 posted23 Apr 2008 (estimated)
- Study startApr 2006
- Primary completionMar 2010
- Study completionApr 2010
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 Arterial Occlusive 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Thomas Zeller, Herz-Zentrums Bad Krozingen
- Investigators
- Thomas Zeller, MD, Principal investigator, Herz-Zentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664963
- Sponsor's protocol ID
- YUKON-BTK v3.0
- Acronym
- YUKON-BTK
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2008
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rastan A, Brechtel K, Krankenberg H, Zahorsky R, Tepe G, Noory E, Schwarzwalder U, Macharzina R, Schwarz T, Burgelin K, Sixt S, Tubler T, Neumann FJ, Zeller T. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012 Aug 14;60(7):587-91. doi: 10.1016/j.jacc.2012.04.035.
PubMed 22878166Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.
PubMed 21622669
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
- ClinicalTrials.gov ID
- NCT00664963
- Acronym / sponsor ID
- YUKON-BTK / YUKON-BTK v3.0
- Conditions
- Arterial Occlusive Diseases
- Keywords
- Arterial Occlusive Diseases, Peripheral Vascular Diseases, Drug eluting stent, Restenosis, Below the knee, Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Apr 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.
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.
Detailed description
Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Implantation of YUKON Sirolimus-eluting StentYUKON Sirolimus-eluting Stent |
| 2 | Active comparator | Device: Implantation of YUKON Stent (uncoated)YUKON Stent (uncoated) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
- De-novo stenosis of > 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
- Target lesion length of ≤ 45 mm
Key exclusion criteria (3 listed)
- Coagulation disorder
- Known allergy to contrast medium
- Contraindications to antiplatelet therapy 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 |
|---|---|---|
| Implantation of YUKON Sirolimus-eluting StentImplantation of YUKON Sirolimus-eluting Stent | Device | 1 |
| Implantation of YUKON Stent (uncoated)Implantation of YUKON Stent (uncoated) | Device | 2 |
Primary outcome
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
Time frame: 12 months
1 secondary outcome
Number of reinterventions of target vessel
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Derived from this study: PubMed 22878166Rastan A, Brechtel K, Krankenberg H, Zahorsky R, Tepe G, Noory E, Schwarzwalder U, Macharzina R, Schwarz T, Burgelin K, Sixt S, Tubler T, Neumann FJ, Zeller T. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012 Aug 14;60(7):587-91. doi: 10.1016/j.jacc.2012.04.035.
- Derived from this study: PubMed 21622669Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.
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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.
Thomas Zeller, MD principal investigator
Herz-Zentrum Bad Krozingen
3 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 Implantation of YUKON Sirolimus-eluting Stent and Implantation of YUKON Stent (uncoated) in people with Arterial Occlusive Diseases, run by Herz-Zentrums Bad Krozingen at 3 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 3 inclusion and 3 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) (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 NCT00664963, 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 17 Dec 2014.