Clinical trial NCT00986752: Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease
Official title: Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Vascular Diseases
Keywords: stent
atherectomy
paclitaxel-eluting balloon
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 150
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 purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

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. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern.

Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another 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 this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.

Eligibility criteria: Inclusion Criteria:

* Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
* Written informed consent

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Previous stenting of the SFA
* Popliteal stenosis \>70%
* Severe renal insufficiency

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
measure: Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum
city: Muenchen
country: Germany
facility: I. Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum München
name: Adnan Kastrati, MD
role: STUDY_CHAIR
affiliation: Klinikum rechts der Isar
name: Ilka Ott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Hiendlmayer R, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH). Circulation. 2017 Jun 6;135(23):2218-2226. doi: 10.1161/CIRCULATIONAHA.116.025329. Epub 2017 Apr 19.