Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

Peripheral Vascular Diseases Clinical Trial

— ISAR-STATH  

Official title:

Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00986752
• Other study ID #: GE IDE No. B00101
• Status: Recruiting
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: March 6, 2014
• Start date: July 2009
• Est. completion date: March 2015

Study information

• Verified date: January 2010
• Source: Deutsches Herzzentrum Muenchen
• Contact: Klaus Tiroch, MD
• Phone: +49-89-1218
• Email: tiroch[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Stenting (Smart Stent)
Nitinol stent
• Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).

Procedure:
• Atherectomy (SilverHawk device)
Atherectomy

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum	Muenchen
Germany	I. Medizinische Klinik, Klinikum rechts der Isar	Muenchen

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage diameter stenosis		6 months	No
Secondary	All-cause mortality		6 and 24 months	Yes
Secondary	Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)		6 months	Yes
Secondary	Time to onset of any of MAPE.		3-24 months	Yes
Secondary	Binary restenosis rate		6 months	No
Secondary	Percentage diameter stenosis in duplex ultrasound		6 and 24 months	No
Secondary	Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)		3 and 6 months	No