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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)

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ClinicalTrials.gov Identifier: NCT00906022
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date February 9, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00906022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Patients With Symptomatic Critical Limb Ischemia
  • Severe Intermittent Claudication
Intervention  ICMJE
  • Device: Astron Pulsar Stent
    Stenting with Astron Pulsar
  • Device: PTA alone
    Balloon angioplasty alone
Study Arms  ICMJE
  • Experimental: Astron Pulsar Stent
    Device: Astron Pulsar Stent
    Intervention: Device: Astron Pulsar Stent
  • Active Comparator: PTA alone
    Device: Balloon angioplasty alone
    Intervention: Device: PTA alone
Publications * Schulte KL, Pilger E, Schellong S, Tan KT, Baumann F, Langhoff R, Torsello G, Zeller T, Amendt K, Brodmann M; EXPAND Investigators. Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study). J Endovasc Ther. 2015 Oct;22(5):690-7. doi: 10.1177/1526602815598955. Epub 2015 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
94
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2009)
170
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00906022
Other Study ID Numbers  ICMJE C0801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik AG
Study Sponsor  ICMJE Biotronik AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biotronik AG
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP