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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT00906022
First received: May 20, 2009
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Patients With Symptomatic Critical Limb Ischemia
Severe Intermittent Claudication
Device: Astron Pulsar Stent
Device: PTA alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: May 2009
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Astron Pulsar Stent
Device: Astron Pulsar Stent
Device: Astron Pulsar Stent
Stenting with Astron Pulsar
Active Comparator: PTA alone
Device: Balloon angioplasty alone
Device: PTA alone
Balloon angioplasty alone

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 50 years
  2. Patient has signed the patient informed consent.
  3. Patient is willing to adhere to the follow up time points and to follow the requirements during the study
  4. Patient has symptomatic critical limb ischemia or severe intermittent claudication classified as Rutherford category 3, 4 or 5.
  5. 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.
  6. 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)
  7. Reference vessel diameter is between 2.5 and 4.0 mm.
  8. 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.
  9. Haemodynamically significant inflow stenoses of vessels above the knee were successfully treated before.
  10. Lesions must be crossed successfully with a guide wire and guide wire must be within the true lumen of the distal vessel.

Notes:

  • Target vessel has to be defined; Target vessel = vessel with target lesion to be treated
  • Target vessel: Multiple or diffused lesions with total length > 190 mm => inclusion criteria are NOT fulfilled
  • NON-target vessel(s): haemodynamically significant lesion can be treated according to investigator's discretion

Exclusion Criteria:

  1. Patient refuses treatment.
  2. Patient is legally, physically or mentally unable to give consent.
  3. ABI / TBI measurement is impossible.
  4. Target lesion is pre-treated.
  5. Target lesion lies within or adjacent to an aneurysm.
  6. Acute thrombus present in the target limb.
  7. The reference vessel diameter is not suitable for available stent size (RVD < 2.5 and > 4.0 mm).
  8. Length of lesion requires more than one treatment device (lesion length > 190 mm)
  9. 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.
  10. Life-expectancy less than 12 months at the time of screening.
  11. Patient has a known allergy to heparin, aspirin, clopidogrel or other anticoagulant/ antiplatelet therapies, to nickel or contrast media or is unwilling to tolerate such therapies.
  12. Patient has bleeding diatheses
  13. Patient is currently enrolled in another investigational device or drug trial.
  14. Patient took part in another investigational device or drug trial within 3 months prior to screening.
  15. Patient is currently breast-feeding, pregnant or intends to become pregnant.
  16. Myocardial infarction without coronary revascularization < 6 months prior to screening and with coronary revascularization < 1 month prior to screening.
  17. Previous coronary or peripheral bypass surgery within 30 days prior to screening.
  18. Patient had a calculated creatinine clearance < 30 ml/min within 30 days prior to screening.
  19. Patient had a stroke or TIA within the last 6 months prior to screening.
  20. Patient had a major amputation of the target limb (defined as above the ankle) at the time of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906022

Locations
Germany
Gefässzentrum Berlin, Evangelisches Krankenhaus KEH
Berlin, Germany, 10365
Sponsors and Collaborators
Biotronik AG
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT00906022     History of Changes
Other Study ID Numbers: C0801
Study First Received: May 20, 2009
Last Updated: November 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik AG:
Below the Knee
Infrapopliteal arteries
nitinol
limb ischemia
claudication
self-expanding stent
duplex
angiography

Additional relevant MeSH terms:
Intermittent Claudication
Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014