Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

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)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01083394

Acronym

ISAR-PEBIS

Enrollment

Registered

2010-03-09

Start date

2010-03-31

Completion date

2015-12-31

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

Keywords

PTA, paclitaxel, restenosis

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.

Interventions

DEVICEPTA

PTA using a conventional balloon

DEVICEPTA with PEB

PTA using a paclitaxel eluting balloon

PROCEDUREPercutaneous Transluminal Angioplasty (PTA)

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage diameter stenosis	6 months

Secondary

Measure	Time frame
All-cause mortality	6 and 24 months
Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)	6 Months
Time to onset of any of MAPE	3-24 months
Binary restenosis rate	6 months
Percentage diameter stenosis in duplex ultrasound	6 and 24 months

Countries

Germany

Contacts

Primary ContactJulinda Mehilli, MD

mehilli@dhm.mhn.de+49 89 12 18

Backup ContactIlka V. Ott, MD

ott@dhm.de+49 89 41 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026