In-stent Stenosis of Infrapopliteal ArteriesPhase 3BAIRNCT01398033
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
A Phase 3 study testing paclitaxel-coated balloon and non-coated balloon in people with In-stent Stenosis of Infrapopliteal Arteries, run by Herz-Zentrums Bad Krozingen at 1 site in Germany.
Trial summary
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- In-stent Stenosis of Infrapopliteal Arteries
- What is being tested?
- paclitaxel-coated balloon and non-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Sep 2014
- Phase
- Phase 3
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 years
- Signed declaration of consent
- Subject is willing and able to participate in all the planned evaluations of the study protocol
- Arterial occlusion disease stage 3 - 6 Rutherford-Becker
- Subject with an in-stent stenosis over 70% of the vascular lumen diameter of the tibioperoneal trunc and/or the posterior tibial artery and/or of the anterior tibial artery and/or peroneal artery. Here vascular segments, which are affected continuous (including stent), proximal or distal of the stent by a relevant (re)stenosis, are treated according to randomisation
- The length of the target lesion(s) should not exceed 290mm
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- In total four drug-coated balloons are enough to treat a maximum of two lesions
- The target lesion's lumen diameter is between 2.0mm and 3.5mm
- Successful passage of the wire to the target lesion before randomisation
Who cannot join
- Coagulopathy
- Pregnancy
- Contraindications for antiplatelet or heparin
- Factors which exclude a follow up
- Life expectancy <12 months
- Known allergies to contrast agents and/or Clopidogrel and/or Aspirin
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- >50% stenosis distal of the target lesion
- Visible thrombus in the target lesion
- Lytic therapy 72 hours before the planned intervention
- Aneurysm of the femoral or popliteal artery
- Intervention of focal lesions of the femoral or popliteal artery may be carried out before treatment of the target lesion in order to enhance the inflow in the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.
The aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.
Read the detailed description
In this prospective, double-blind, randomised, multi-centre study the use of the already certified coated balloon and an uncoated balloon is evaluated in patients with in-stent restenoses/reocclusions of the lower limb artery. The whole lesion length should be covered by the balloon so that proximal and distal overlap of the lesion by a minimum of 5mm is assured. Based on the current literature the average restenoses rate of the lower limb arteries after percutaneous transluminal angioplasty of an in-stent restenosis is 70% after 6 months. Assuming the restenosis rate reduces to 30% after percutaneous transluminal angioplasty using a drug-coated balloon, with a significance level of Alpha=0.05 (bilateral) and a power Beta=0.8, the enrolment of 100 patients is required in order to show a significant difference between treatment groups, considering a dropout rate of 30%. The choice of treatment will be distributed in a randomised, double blind procedure.
The study duration per patient is 2 years. Clinical follow-up evaluations will take place after 3 and 6 months and after 1 and 2 years. After 3 month and 12 months an angiography of the target vessel will be performed.
- Being tested
- paclitaxel-coated balloon, non-coated balloon
- Keywords
- infrapopliteal arteries, In-stent stenosis, long lesions, drug-coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloonDevice
Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
non-coated balloonDevice
percutaneous transluminal angioplasty with a non-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Active comparator | 1. pre-dilatation of the target lesion with a non-coated balloon.
2. treatment of the target lesion with the paclitaxel-coated balloon Receives: Device: paclitaxel-coated balloon |
| non-coated balloon | Placebo comparator | Treatment of the target lesion with plain balloon angioplasty. Receives: Device: non-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency of target lesion assessed by quantitative angiography
Measured: 3 months after index procedure
Secondary outcomes (1)
Secondary patency of the target lesion assessed by quantitative angiography
Measured: 12 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startApr 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: Study stopped due to lack of patient inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Stenosis of Infrapopliteal ArteriesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Heart Center Freiburg - Bad Krozingen
- Responsible party
- Principal investigator, Aljoscha Rastan, Herz-Zentrums Bad Krozingen
- Investigators
- Aljoscha Rastan, M.D., Principal investigator, Herzzentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398033
- Sponsor's protocol ID
- FW-014-1
- Acronym
- BAIR
- Status last verified
- Aug 2015
- First submitted
- 19 Jul 2011
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
- ClinicalTrials.gov ID
- NCT01398033
- Acronym / sponsor ID
- BAIR / FW-014-1
- Keywords
- infrapopliteal arteries, In-stent stenosis, long lesions, drug-coated balloon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to lack of patient inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Collaborators
- University Heart Center Freiburg - Bad Krozingen
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 20 Jul 2011 (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.
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.
The aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.
Detailed description
In this prospective, double-blind, randomised, multi-centre study the use of the already certified coated balloon and an uncoated balloon is evaluated in patients with in-stent restenoses/reocclusions of the lower limb artery. The whole lesion length should be covered by the balloon so that proximal and distal overlap of the lesion by a minimum of 5mm is assured. Based on the current literature the average restenoses rate of the lower limb arteries after percutaneous transluminal angioplasty of an in-stent restenosis is 70% after 6 months. Assuming the restenosis rate reduces to 30% after percutaneous transluminal angioplasty using a drug-coated balloon, with a significance level of Alpha=0.05 (bilateral) and a power Beta=0.8, the enrolment of 100 patients is required in order to show a significant difference between treatment groups, considering a dropout rate of 30%. The choice of treatment will be distributed in a randomised, double blind procedure.
The study duration per patient is 2 years. Clinical follow-up evaluations will take place after 3 and 6 months and after 1 and 2 years. After 3 month and 12 months an angiography of the target vessel will be performed.
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 |
|---|---|---|
| Drug-coated balloon | Active comparator | Device: paclitaxel-coated balloon1. pre-dilatation of the target lesion with a non-coated balloon. 2. treatment of the target lesion with the paclitaxel-coated balloon |
| non-coated balloon | Placebo comparator | Device: non-coated balloonTreatment of the target lesion with plain balloon angioplasty. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age over 50 years
- Signed declaration of consent
- Subject is willing and able to participate in all the planned evaluations of the study protocol
- Arterial occlusion disease stage 3 - 6 Rutherford-Becker
- Subject with an in-stent stenosis over 70% of the vascular lumen diameter of the tibioperoneal trunc and/or the posterior tibial artery and/or of the anterior tibial artery and/or peroneal artery. Here vascular segments, which are affected continuous (including stent), proximal or distal of the stent by a relevant (re)stenosis, are treated according to randomisation
Key exclusion criteria (11 listed)
- Coagulopathy
- Pregnancy
- Contraindications for antiplatelet or heparin
- Factors which exclude a follow up
- Life expectancy <12 months
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 |
|---|---|---|
| paclitaxel-coated balloonBalloon is coated with paclitaxel in a concentration of 3µg/mm2. | Device | Drug-coated balloon |
| non-coated balloonpercutaneous transluminal angioplasty with a non-coated balloon | Device | non-coated balloon |
Primary outcome
primary patency of target lesion assessed by quantitative angiography
Time frame: 3 months after index procedure
1 secondary outcome
Secondary patency of the target lesion assessed by quantitative angiography
Time frame: 12 months after index procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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.
Aljoscha Rastan, M.D. principal investigator
Herzzentrum Bad Krozingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paclitaxel-coated balloon and non-coated balloon in people with In-stent Stenosis of Infrapopliteal Arteries, run by Herz-Zentrums Bad Krozingen at 1 site 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 of target lesion assessed by quantitative angiography (time frame: 3 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2015.