Peripheral Arterial DiseaseEffPacNCT02540018
Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis
A study testing Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries and Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter in people with Peripheral Arterial Disease, run by Jena University Hospital at 11 sites in Germany.
Trial summary
The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel drug-eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term patency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries and Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 11 sitesGermany
- Study dates
- 15 Sep 2015to 14 Jan 2022
- 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
- Age ≥18 years
- Subject must agree to undergo the 6-month angiographic and clinical follow-up (at 12 month post-procedure)
- Peripheral vascular disease Rutherford class 2-4
- De novo stenotic/re-stenotic lesion or occlusive lesions in the superficial femoral (SFA) and/or popliteal arteries (PA)
- If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
- ≥70% diameter stenosis or occlusion
Show all 13Show fewer
- Target lesion length: ≤15 cm (TASC II A and B)
- Only one lesion per limb and per patient can be treated (see definition chapter 6.5)
- ≥ one patent intrapopliteal run-off artery to the foot of the index limb
- Successful endoluminal guidewire passage through the target lesion
- Predilatation prior to randomization
- Life expectancy, in the investigators opinion of at least one year
- Subject is able to verbally acknowledge and understand the aim of this trial and is willing and able to provide informed consent
Who cannot join
- Previous surgery in the target vessel
- Major amputation in the same limb as the target lesion
- Presence of aneurysm in the target vessel
- Acute myocardial infarction within 30 days before intervention
- Severely calcified target lesions in the SFA/PA resistant to PTA
- Subjects requiring different treatment or raising serious safety concern regarding the procedure or the required medication
Show all 21Show fewer
- Women of childbearing potential expect women with the following criteria:
- post-menopausal (12 month natural amenorrhea or 6 month amenorrhea with serum FSH > 40mlU/ml)
- sterilization 86 weeks after bilateral ovariectomy with or without hysterectomy
- using an effective method of birth control for the duration of the trial: implants, injectables, combined oral contraceptives, intrauterine device (in place for a period of at least 2 months prior to screening) and with negative serum pregnancy test
- sexual abstinence
- vasectomy partner
- Pregnant and nursing women
- Acute thrombus, stent or aneurysm in the index limb or vessel
- Renal insufficiency with a serum creatinine >2.0 mg/dL at baseline
- Platelet count <50 G/l or >600 G/l at baseline
- Known hypersensitivity or contraindication to contrast agent that cannot be adequately pre-medicated
- Subjects with known allergies against Paclitaxel
- Subjects with intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
- Dialysis or immunosuppressant therapy
- Current participation (or within the last 3 months) in another interventional study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Klinikum Arnsberg Angiologie
Arnsberg, Thuringia, 59759
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie
Berlin, 13347
Angiologikum Hamburg
Hamburg, 22527
Universitätsklinikum Heidelberg
Heidelberg, 69120
University Hospital Jena, Radiology
Jena, Thuringia, 07747
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad-Langensteinbach, Baden-Wurttemberg, 76307
Westpfalz-Klinikum GmbH Standort II Kusel
Kusel, Rhineland-Palatinate, 66869
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt
München, Bavaria, 80336
Medinos Kliniken Sonneberg
Sonneberg, Thuringia, 96515
About this study
Official title: Multicenter Randomized Controlled Trial to Assess the Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion
The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel drug-eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term patency.
Read the detailed description
The investigational medical device represents the Paclitaxel drug-eluting Luminor®-35 balloon catheter which is based on a proprietary transfertech coating technology. This has been engineered to improve clinical efficacy by optimizing coating properties and device functionalities. This allows a homogeneous and precise Paclitaxel concentration of 3 μg/mm2 on the PTA balloon surface. The balloon dilatation procedure, including deployment to the target lesion and balloon inflation, deflation and retrieval, is performed under fluoroscopic observation. All sites shall have access to an emergency unit to perform also interventions as bypass surgery e.g. in case of failed percutaneous transluminal angioplasty (PTA). The patient is positioned on the angiographic table and draped in a sterile fashion. The standard vascular access represents the ipsilateral or contralateral femoral artery in accordance to the target vessel. The endovascular procedure can be performed in a direct antegrade or a cross-over retrograde technique.
An introducer sheath will be inserted over a guidewire. 5.000 I.U. heparin is injected i.a. to pre-vent peri-procedural thrombotic events. Alternative peri-procedural anti-coagulation regimens may be applied if justified by individual patient requirements. An endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion is mandatory for study inclusion.
A POBA PTA balloon of appropriate balloon diameter and length, and catheter working length is selected according to the characteristics of the target vessel and lesion for the pre-dilation and assessed by angiography (DSA or XA). A ruler has to be adjacent to the target vessel. After pre-dilatation of the target lesion an angiographic assessment will be performed (DSA or XA). A ruler has to be adjacent to the target vessel.
Randomization will be performed by envelope pull. The treatment group represents the Lumi-nor® DEB and the control group POBA applying a CE-marked non-drug-eluting PTA balloon catheter. In patients with peripheral artery disease, quantitative vascular angiography (QVA) is essential for the analysis of the degree of the arterial stenosis. For quantitative assessment of stenotic lesions, the residual lumen at the lesion site is compared with the lumen at a reference site.
QVA will be assessed by an independent core lab. The assessment during the angioplasty is performed pre- and post-procedure, at 6 months follow-up and any unscheduled procedure if necessary. Follow-up (FU) assessments will occur at pre-discharge, 6, 12 and 24 months following the study procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries, Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter
- Keywords
- DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal ArteriesDevice
Also called DEB
Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization.
Luminor35®-DEB PTA catheter is applied.
Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheterDevice
Also called POBA
Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-coated Luminor® Balloon Catheter | Active comparator | The balloon dilatation procedure, including deployment to the target lesion and balloon inflation, deflation and retrieval, is performed under fluoroscopic observation. An endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion is mandatory. After pre-dilatation of the target lesion an angiographic assessment will be performed (DSA or XA). Randomization will be performed by envelope pull. The treatment group represents the Luminor® DEB PTA. After dilation of the target lesion, the PTA catheter is withdrawn through the introducer sheath, and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications. A final run-off angiography (DSA or XA) of the BTK arteries is required. Receives: Device: Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries |
| Uncoated Balloon Catheter | Active comparator | Identical procedure also for control arm with PTA balloon (see below): After pre-dilatation, randomization will be performed by envelope pull. The control group requires an uncoated balloon catheter. After dilation of the target lesion, the PTA catheter is withdrawn and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications. A final run-off angiography (DSA or XA) of the BTK arteries is required. Receives: Device: Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Late Lumen Loss (LLL)
Change in Late Lumen Loss (LLL), defined as difference between the diameters (in mm) at 6 months follow-up minus post-procedure.
Measured: at baseline and after 6 months
Secondary outcomes (8)
Revascularisation of TVR
Freedom of target vessel revascularization (TVR)
Measured: after 6 months and 12 months
Revascularisation of TLR
Freedom from target lesion revascularization (TLR)
Measured: after 6 months and 12 months
Change in Rutherford classification
Change of Rutherford stage to baseline at Follow-up
Measured: after 6 months and 12 months
Change of ABI
Decrease in the ankle-brachial-index
Measured: after 6 months and 12 months
Change of Life Quality
Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ5D questionnaire to baseline at Follow-up
Measured: after 6 months and 12 months
Absence of amputation
Major and minor amputation rate at the index limb
Measured: after 6 months and 12 months
Bailouts
Number of bailouts
Measured: after 6 months and 12 months
Mortality
Mortality rate independently of the direct cause
Measured: after 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start15 Sep 2015
- Primary completionDec 2016
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- iVascular S.L.U., KKS Netzwerk
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
- Investigators
- René Aschenbach, PD Dr. med., Principal investigator, University Hospital Jena, Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540018
- Sponsor's protocol ID
- CIV-15-03-013204
- Acronym
- EffPac
- Status last verified
- Mar 2023
- First submitted
- 17 Aug 2015
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Teichgraber U, Lehmann T, Ingwersen M, Aschenbach R, Zeller T, Brechtel K, Blessing E, Lichtenberg M, von Flotow P, Heilmeier B, Sixt S, Brucks S, Erbel C, Beschorner U, Werk M, Riambau V, Wienke A, Klumb C, Thieme M, Scheinert D. Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1774-1783. doi: 10.1007/s00270-022-03265-1. Epub 2022 Sep 11.
PubMed 36088609Teichgraber U, Lehmann T, Aschenbach R, Scheinert D, Zeller T, Brechtel K, Blessing E, Lichtenberg M, Sixt S, Brucks S, Beschorner U, Klumb CT, Thieme M; Collaborators. Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. EuroIntervention. 2020 Apr 3;15(18):e1633-e1640. doi: 10.4244/EIJ-D-19-00292.
PubMed 31687933Teichgraber U, Aschenbach R, Scheinert D, Zeller T, Brechtel K, Thieme M, Blessing E, Treitl M, Lichtenberg M, von Flotow P, Vogel B, Werk M, Riambau V, Wienke A, Lehmann T, Sixt S. The effectiveness of the paclitaxel-coated Luminor(R) balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial. Trials. 2016 Oct 28;17(1):528. doi: 10.1186/s13063-016-1657-x.
PubMed 27793175
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial to Assess the Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion
- ClinicalTrials.gov ID
- NCT02540018
- Acronym / sponsor ID
- EffPac / CIV-15-03-013204
- Conditions
- Peripheral Arterial Disease
- Keywords
- DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- iVascular S.L.U., KKS Netzwerk
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 3 Sep 2015 (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 aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel drug-eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term patency.
Detailed description
The investigational medical device represents the Paclitaxel drug-eluting Luminor®-35 balloon catheter which is based on a proprietary transfertech coating technology. This has been engineered to improve clinical efficacy by optimizing coating properties and device functionalities. This allows a homogeneous and precise Paclitaxel concentration of 3 μg/mm2 on the PTA balloon surface. The balloon dilatation procedure, including deployment to the target lesion and balloon inflation, deflation and retrieval, is performed under fluoroscopic observation. All sites shall have access to an emergency unit to perform also interventions as bypass surgery e.g. in case of failed percutaneous transluminal angioplasty (PTA). The patient is positioned on the angiographic table and draped in a sterile fashion. The standard vascular access represents the ipsilateral or contralateral femoral artery in accordance to the target vessel. The endovascular procedure can be performed in a direct antegrade or a cross-over retrograde technique.
An introducer sheath will be inserted over a guidewire. 5.000 I.U. heparin is injected i.a. to pre-vent peri-procedural thrombotic events. Alternative peri-procedural anti-coagulation regimens may be applied if justified by individual patient requirements. An endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion is mandatory for study inclusion.
A POBA PTA balloon of appropriate balloon diameter and length, and catheter working length is selected according to the characteristics of the target vessel and lesion for the pre-dilation and assessed by angiography (DSA or XA). A ruler has to be adjacent to the target vessel. After pre-dilatation of the target lesion an angiographic assessment will be performed (DSA or XA). A ruler has to be adjacent to the target vessel.
Randomization will be performed by envelope pull. The treatment group represents the Lumi-nor® DEB and the control group POBA applying a CE-marked non-drug-eluting PTA balloon catheter. In patients with peripheral artery disease, quantitative vascular angiography (QVA) is essential for the analysis of the degree of the arterial stenosis. For quantitative assessment of stenotic lesions, the residual lumen at the lesion site is compared with the lumen at a reference site.
QVA will be assessed by an independent core lab. The assessment during the angioplasty is performed pre- and post-procedure, at 6 months follow-up and any unscheduled procedure if necessary. Follow-up (FU) assessments will occur at pre-discharge, 6, 12 and 24 months following the study procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated Luminor® Balloon Catheter | Active comparator | Device: Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal ArteriesThe balloon dilatation procedure, including deployment to the target lesion and balloon inflation, deflation and retrieval, is performed under fluoroscopic observation. An endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion is mandatory. After pre-dilatation of the target lesion an angiographic assessment will be performed (DSA or XA). Randomization will be performed by envelope pull. The treatment group represents the Luminor® DEB PTA. After dilation of the target lesion, the PTA catheter is withdrawn through the introducer sheath, and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications. A final run-off angiography (DSA or XA) of the BTK arteries is required. |
| Uncoated Balloon Catheter | Active comparator | Device: Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheterIdentical procedure also for control arm with PTA balloon (see below): After pre-dilatation, randomization will be performed by envelope pull. The control group requires an uncoated balloon catheter. After dilation of the target lesion, the PTA catheter is withdrawn and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications. A final run-off angiography (DSA or XA) of the BTK arteries is required. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years
- Subject must agree to undergo the 6-month angiographic and clinical follow-up (at 12 month post-procedure)
- Peripheral vascular disease Rutherford class 2-4
- De novo stenotic/re-stenotic lesion or occlusive lesions in the superficial femoral (SFA) and/or popliteal arteries (PA)
- If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
Key exclusion criteria (21 listed)
- Previous surgery in the target vessel
- Major amputation in the same limb as the target lesion
- Presence of aneurysm in the target vessel
- Acute myocardial infarction within 30 days before intervention
- Severely calcified target lesions in the SFA/PA resistant to PTA
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 |
|---|---|---|
| Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal ArteriesAlso: DEBEndoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization. Luminor35®-DEB PTA catheter is applied. | Device | Paclitaxel-coated Luminor® Balloon Catheter |
| Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheterAlso: POBAEndoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied. | Device | Uncoated Balloon Catheter |
Primary outcome
Change in Late Lumen Loss (LLL)
Time frame: at baseline and after 6 months
Change in Late Lumen Loss (LLL), defined as difference between the diameters (in mm) at 6 months follow-up minus post-procedure.
8 secondary outcomes
Revascularisation of TVR
Time frame: after 6 months and 12 months
Revascularisation of TLR
Time frame: after 6 months and 12 months
Change in Rutherford classification
Time frame: after 6 months and 12 months
Change of ABI
Time frame: after 6 months and 12 months
Change of Life Quality
Time frame: after 6 months and 12 months
Absence of amputation
Time frame: after 6 months and 12 months
Bailouts
Time frame: after 6 months and 12 months
Mortality
Time frame: after 6 months and 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 13 Mar 2023.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 36088609Teichgraber U, Lehmann T, Ingwersen M, Aschenbach R, Zeller T, Brechtel K, Blessing E, Lichtenberg M, von Flotow P, Heilmeier B, Sixt S, Brucks S, Erbel C, Beschorner U, Werk M, Riambau V, Wienke A, Klumb C, Thieme M, Scheinert D. Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1774-1783. doi: 10.1007/s00270-022-03265-1. Epub 2022 Sep 11.
- Derived from this study: PubMed 31687933Teichgraber U, Lehmann T, Aschenbach R, Scheinert D, Zeller T, Brechtel K, Blessing E, Lichtenberg M, Sixt S, Brucks S, Beschorner U, Klumb CT, Thieme M; Collaborators. Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. EuroIntervention. 2020 Apr 3;15(18):e1633-e1640. doi: 10.4244/EIJ-D-19-00292.
- Derived from this study: PubMed 27793175Teichgraber U, Aschenbach R, Scheinert D, Zeller T, Brechtel K, Thieme M, Blessing E, Treitl M, Lichtenberg M, von Flotow P, Vogel B, Werk M, Riambau V, Wienke A, Lehmann T, Sixt S. The effectiveness of the paclitaxel-coated Luminor(R) balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial. Trials. 2016 Oct 28;17(1):528. doi: 10.1186/s13063-016-1657-x.
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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.
René Aschenbach, PD Dr. med. principal investigator
University Hospital Jena, Radiology
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries and Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter in people with Peripheral Arterial Disease, run by Jena University Hospital at 11 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 13 inclusion and 21 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Change in Late Lumen Loss (LLL) (time frame: at baseline and after 6 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 NCT02540018, which also lists 4 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 13 Mar 2023.