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.

Biotronik AG1 site in 1 country94 target enrollmentMay 2009

ConditionsPatients With Symptomatic Critical Limb Ischemia Severe Intermittent Claudication

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Patients With Symptomatic Critical Limb Ischemia
Sponsor: Biotronik AG
Enrollment: 94
Locations: 1
Primary Endpoint: Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 50 years
•Patient has signed the patient informed consent.
•Patient is willing to adhere to the follow up time points and to follow the requirements during the study
•Patient has symptomatic critical limb ischemia or severe intermittent claudication classified as Rutherford category 3, 4 or
•Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries below the radiographic level of the knee joint and above the level of the ankle (includes the peroneotibial trunk, anterior tibial artery, posterior tibial artery and peroneal artery, excludes the popliteal artery), as determined by pre-procedure intra-arterial DSA (preferred) or conventional angiography.
•Target (study) lesion to be treated is a de novo lesion (lesion ≤ 190 mm length). NOTE: Multiple or diffused lesion treatment is allowed as long as total lesion length ≤ 190 mm)
•Reference vessel diameter is between 2.5 and 4.0 mm.
•Target vessel: It must be possible to follow the vessel run-off to the foot and/or the wound area. NOTE: Patients with incomplete or abnormal anatomical run-off are NOT excluded. Important is to see that the there is a run-off to the foot and/or wound area even if collaterals are involved.
•Haemodynamically significant inflow stenoses of vessels above the knee were successfully treated before.
•Lesions must be crossed successfully with a guide wire and guide wire must be within the true lumen of the distal vessel.

Exclusion Criteria

•Patient refuses treatment.
•Patient is legally, physically or mentally unable to give consent.
•ABI / TBI measurement is impossible.
•Target lesion is pre-treated.
•Target lesion lies within or adjacent to an aneurysm.
•Acute thrombus present in the target limb.
•The reference vessel diameter is not suitable for available stent size (RVD \< 2.5 and \> 4.0 mm).
•Length of lesion requires more than one treatment device (lesion length \> 190 mm)
•Hybrid technique (bypass surgery and peripheral intervention with PTA or stent during the same session) is not allowed. Note: Allowed is if the patient got a P1 or P3 bypass in a previous session and it is possible to treat a distal lesion through that bypass in a separate session. Time window between bypass surgery and planned intervention must be at least 30 days.
•Life-expectancy less than 12 months at the time of screening.

Outcomes

Primary Outcomes

Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale.

Time Frame: 12 months

Secondary Outcomes

MAE rate, amputation rate, mortality rate, Maximum Walking Distance and Pain Free Walking Distance, Quality of Life, Binary restenosis rate, technical and device success, hemodynamic outcome(6 and 12 months)