Back to resultsEffectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis (EffPac)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
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
Sites / Locations
- SRH Klinikum Karlsbad-Langensteinbach
- Herzzentrum Bad Krozingen
- Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt
- Westpfalz-Klinikum GmbH Standort II Kusel
- Universitätsklinikum Leipzig
- Klinikum Arnsberg Angiologie
- University Hospital Jena, Radiology
- Medinos Kliniken Sonneberg
- Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie
- Angiologikum Hamburg
- Universitätsklinikum Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paclitaxel-coated Luminor® Balloon Catheter
Uncoated Balloon Catheter
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Revascularisation of TVR
Freedom of target vessel revascularization (TVR)
Revascularisation of TLR
Freedom from target lesion revascularization (TLR)
Change in Rutherford classification
Change of Rutherford stage to baseline at Follow-up
Change of ABI
Decrease in the ankle-brachial-index
Change of Life Quality
Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ5D questionnaire to baseline at Follow-up
Absence of amputation
Major and minor amputation rate at the index limb
Bailouts
Number of bailouts
Mortality
Mortality rate independently of the direct cause
Full Information
NCT ID
NCT02540018
First Posted
August 17, 2015
Last Updated
March 10, 2023
Sponsor
Jena University Hospital
Collaborators
iVascular S.L.U., KKS Netzwerk
1. Study Identification
Unique Protocol Identification Number
NCT02540018
Brief Title
Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis
Acronym
EffPac
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
Collaborators
iVascular S.L.U., KKS Netzwerk
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-coated Luminor® Balloon Catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Uncoated Balloon Catheter
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries
Other Intervention Name(s)
DEB
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter
Other Intervention Name(s)
POBA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Late Lumen Loss (LLL)
Description
Change in Late Lumen Loss (LLL), defined as difference between the diameters (in mm) at 6 months follow-up minus post-procedure.
Time Frame
at baseline and after 6 months
Secondary Outcome Measure Information:
Title
Revascularisation of TVR
Description
Freedom of target vessel revascularization (TVR)
Time Frame
after 6 months and 12 months
Title
Revascularisation of TLR
Description
Freedom from target lesion revascularization (TLR)
Time Frame
after 6 months and 12 months
Title
Change in Rutherford classification
Description
Change of Rutherford stage to baseline at Follow-up
Time Frame
after 6 months and 12 months
Title
Change of ABI
Description
Decrease in the ankle-brachial-index
Time Frame
after 6 months and 12 months
Title
Change of Life Quality
Description
Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ5D questionnaire to baseline at Follow-up
Time Frame
after 6 months and 12 months
Title
Absence of amputation
Description
Major and minor amputation rate at the index limb
Time Frame
after 6 months and 12 months
Title
Bailouts
Description
Number of bailouts
Time Frame
after 6 months and 12 months
Title
Mortality
Description
Mortality rate independently of the direct cause
Time Frame
after 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Aschenbach, PD Dr. med.
Organizational Affiliation
University Hospital Jena, Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
SRH Klinikum Karlsbad-Langensteinbach
City
Karlsbad-Langensteinbach
State/Province
Baden-Wuertemberg
ZIP/Postal Code
76307
Country
Germany
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79189
Country
Germany
Facility Name
Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt
City
München
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH Standort II Kusel
City
Kusel
State/Province
Rheinland-Pfalz
ZIP/Postal Code
66869
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Arnsberg Angiologie
City
Arnsberg
State/Province
Thuringia
ZIP/Postal Code
59759
Country
Germany
Facility Name
University Hospital Jena, Radiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
Medinos Kliniken Sonneberg
City
Sonneberg
State/Province
Thuringia
ZIP/Postal Code
96515
Country
Germany
Facility Name
Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Angiologikum Hamburg
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
36088609
Citation
Teichgraber 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.
Results Reference
derived
PubMed Identifier
31687933
Citation
Teichgraber 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.
Results Reference
derived
PubMed Identifier
27793175
Citation
Teichgraber 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. Erratum In: Trials. 2017 Apr 26;18(1):193.
Results Reference
derived
Learn more about this trial
Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis
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