Severe Intermittent Claudication Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00311805 -
Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)
|
Phase 1 |