Clinical trial NCT01083394: Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery
Official title: Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Vascular Disease
Keywords: PTA
paclitaxel
restenosis
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

Detailed description: The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

Eligibility criteria: Inclusion Criteria:

* Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Not at least one vessel run-off
* Popliteal involvement with stenosis \>70%
* Severe renal insufficiency (GFR \<30 ml/min/m2)
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.

Primary outcomes:
measure: Percentage diameter stenosis
timeFrame: 6 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 6 and 24 months
measure: Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)
timeFrame: 6 Months
measure: Time to onset of any of MAPE
timeFrame: 3-24 months
measure: Binary restenosis rate
timeFrame: 6 months
measure: Percentage diameter stenosis in duplex ultrasound
timeFrame: 6 and 24 months
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: STUDY_CHAIR
affiliation: Klinikum rechts der Isar
name: Ilka V. Ott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial. J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.