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Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis (EffPac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540018
Recruitment Status : Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
iVascular S.L.U.
KKS Netzwerk
Information provided by (Responsible Party):
Ulf Teichgräber, Jena University Hospital

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries Device: Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Paclitaxel-coated Luminor® Balloon Catheter
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.
Device: Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries

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.

Other Name: DEB

Active Comparator: Uncoated Balloon Catheter
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.
Device: Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter
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.
Other Name: POBA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Revascularisation of TVR [ Time Frame: after 6 months and 12 months ]
    Freedom of target vessel revascularization (TVR)

  2. Revascularisation of TLR [ Time Frame: after 6 months and 12 months ]
    Freedom from target lesion revascularization (TLR)

  3. Change in Rutherford classification [ Time Frame: after 6 months and 12 months ]
    Change of Rutherford stage to baseline at Follow-up

  4. Change of ABI [ Time Frame: after 6 months and 12 months ]
    Decrease in the ankle-brachial-index

  5. Change of Life Quality [ Time Frame: after 6 months and 12 months ]
    Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ5D questionnaire to baseline at Follow-up

  6. Absence of amputation [ Time Frame: after 6 months and 12 months ]
    Major and minor amputation rate at the index limb

  7. Bailouts [ Time Frame: after 6 months and 12 months ]
    Number of bailouts

  8. Mortality [ Time Frame: after 6 months and 12 months ]
    Mortality rate independently of the direct cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Subject must agree to undergo the 6-month angiographic and clinical follow-up (at 12 month post-procedure)
  3. Peripheral vascular disease Rutherford class 2-4
  4. De novo stenotic/re-stenotic lesion or occlusive lesions in the superficial femoral (SFA) and/or popliteal arteries (PA)
  5. If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
  6. ≥70% diameter stenosis or occlusion
  7. Target lesion length: ≤15 cm (TASC II A and B)
  8. Only one lesion per limb and per patient can be treated (see definition chapter 6.5)
  9. ≥ one patent intrapopliteal run-off artery to the foot of the index limb
  10. Successful endoluminal guidewire passage through the target lesion
  11. Predilatation prior to randomization
  12. Life expectancy, in the investigators opinion of at least one year
  13. Subject is able to verbally acknowledge and understand the aim of this trial and is willing and able to provide informed consent

Exclusion Criteria:

  1. Previous surgery in the target vessel
  2. Major amputation in the same limb as the target lesion
  3. Presence of aneurysm in the target vessel
  4. Acute myocardial infarction within 30 days before intervention
  5. Severely calcified target lesions in the SFA/PA resistant to PTA
  6. Subjects requiring different treatment or raising serious safety concern regarding the procedure or the required medication
  7. 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
  8. Pregnant and nursing women
  9. Acute thrombus, stent or aneurysm in the index limb or vessel
  10. Renal insufficiency with a serum creatinine >2.0 mg/dL at baseline
  11. Platelet count <50 G/l or >600 G/l at baseline
  12. Known hypersensitivity or contraindication to contrast agent that cannot be adequately pre-medicated
  13. Subjects with known allergies against Paclitaxel
  14. Subjects with intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
  15. Dialysis or immunosuppressant therapy
  16. Current participation (or within the last 3 months) in another interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540018


Locations
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Germany
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Baden-Wuertemberg, Germany, 76307
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany, 79189
Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt
München, Bavaria, Germany, 80336
Westpfalz-Klinikum GmbH Standort II Kusel
Kusel, Rheinland-Pfalz, Germany, 66869
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Klinikum Arnsberg Angiologie
Arnsberg, Thuringia, Germany, 59759
University Hospital Jena, Radiology
Jena, Thuringia, Germany, 07747
Medinos Kliniken Sonneberg
Sonneberg, Thuringia, Germany, 96515
Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie
Berlin, Germany, 13347
Angiologikum Hamburg
Hamburg, Germany, 22527
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Jena University Hospital
iVascular S.L.U.
KKS Netzwerk
Investigators
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Principal Investigator: René Aschenbach, PD Dr. med. University Hospital Jena, Radiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulf Teichgräber, Principal Investigator, Jena University Hospital
ClinicalTrials.gov Identifier: NCT02540018    
Other Study ID Numbers: CIV-15-03-013204
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Keywords provided by Ulf Teichgräber, Jena University Hospital:
DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action