NCT00906022

Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)

EXPAND Study - Self Expanding Nitinol Stent Versus PTA With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication. A Prospective, Multi-center, Randomized Clinical Trail With Follow-up Investigations at 1, 3, 6, and 12 Months.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 51 Years
• Healthy volunteers: Not accepted

Summary

The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months. Patients will be randomized either to treatment with stenting with the Astron Pulsar SE (4 or 5 mm diameter) stent or to PTA with optional bailout stenting in case of PTA failure. The primary objective of this study is to show clinical improvement in the outcome of patients with symptomatic critical limb ischemia or severe intermittent claudication (Rutherford 3, 4, 5) treated with the Astron Pulsar SE (4 or 5 mm diameter) in comparison with PTA or optional bailout stenting in case of PTA failure.

Conditions

• Patients With Symptomatic Critical Limb Ischemia
• Severe Intermittent Claudication

Interventions

Type	Name	Description
DEVICE	Astron Pulsar Stent	Stenting with Astron Pulsar
DEVICE	PTA alone	Balloon angioplasty alone

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-05-21
• Last updated: 2015-02-09

Locations

1 site across 1 country: Germany