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

NCT02540018 | Completed DMC

• 1 other identifier: CIV-15-03-013204
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 11

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.

Conditions

Peripheral Arterial Disease

Keywords

DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and after 6 months

Secondary Outcomes (8)

• Revascularisation of TVR

  after 6 months and 12 months

• Revascularisation of TLR

  after 6 months and 12 months

• Change in Rutherford classification

  after 6 months and 12 months

• Change of ABI

  after 6 months and 12 months

• Change of Life Quality

  after 6 months and 12 months

Study Arms (2)

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 After dilation of the target lesion, the PTA catheter is withdrawn through the introducer sheath, and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications.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.

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 After dilation of the target lesion, the PTA catheter is withdrawn and a post-PTA angiography is performed (DSA or XA) to evaluate the technical result and possible procedural complications.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.

Device: Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter

Interventions

Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries DEVICE

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.

Also known as: DEB

Paclitaxel-coated Luminor® Balloon Catheter

Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter DEVICE

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.

Also known as: POBA

Uncoated Balloon Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead
• iVascular S.L.U.: collaborator
• KKS Netzwerk: collaborator

Study Sites (11)

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad-Langensteinbach, Baden-Wurttemberg, 76307, Germany

Location

Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt

München, Bavaria, 80336, Germany

Location

Westpfalz-Klinikum GmbH Standort II Kusel

Kusel, Rhineland-Palatinate, 66869, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Klinikum Arnsberg Angiologie

Arnsberg, Thuringia, 59759, Germany

Location

University Hospital Jena, Radiology

Jena, Thuringia, 07747, Germany

Location

Medinos Kliniken Sonneberg

Sonneberg, Thuringia, 96515, Germany

Location

Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie

Berlin, 13347, Germany

Location

Angiologikum Hamburg

Hamburg, 22527, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (3)

• 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.

  PMID: 36088609 DERIVED

• 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.

  PMID: 31687933 DERIVED

• 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.

  PMID: 27793175 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty; Catheters

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Equipment and Supplies

Study Officials

• René Aschenbach, PD Dr. med.

  University Hospital Jena, Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: September 3, 2015
• Study Start: September 15, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 14, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

DE (11)