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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)

Primary Purpose

Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Astron Pulsar Stent
PTA alone
Sponsored by
Biotronik AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Symptomatic Critical Limb Ischemia focused on measuring Below the Knee, Infrapopliteal arteries, nitinol, limb ischemia, claudication, self-expanding stent, duplex, angiography

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gefässzentrum Berlin, Evangelisches Krankenhaus KEH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Astron Pulsar Stent

PTA alone

Arm Description

Device: Astron Pulsar Stent

Device: Balloon angioplasty alone

Outcomes

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.

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

Full Information

First Posted
May 20, 2009
Last Updated
February 6, 2015
Sponsor
Biotronik AG
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1. Study Identification

Unique Protocol Identification Number
NCT00906022
Brief Title
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)
Acronym
EXPAND
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
Keywords
Below the Knee, Infrapopliteal arteries, nitinol, limb ischemia, claudication, self-expanding stent, duplex, angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astron Pulsar Stent
Arm Type
Experimental
Arm Description
Device: Astron Pulsar Stent
Arm Title
PTA alone
Arm Type
Active Comparator
Arm Description
Device: Balloon angioplasty alone
Intervention Type
Device
Intervention Name(s)
Astron Pulsar Stent
Intervention Description
Stenting with Astron Pulsar
Intervention Type
Device
Intervention Name(s)
PTA alone
Intervention Description
Balloon angioplasty alone
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
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 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. 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. 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: 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. 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. Patient has bleeding diatheses Patient is currently enrolled in another investigational device or drug trial. Patient took part in another investigational device or drug trial within 3 months prior to screening. Patient is currently breast-feeding, pregnant or intends to become pregnant. Myocardial infarction without coronary revascularization < 6 months prior to screening and with coronary revascularization < 1 month prior to screening. Previous coronary or peripheral bypass surgery within 30 days prior to screening. Patient had a calculated creatinine clearance < 30 ml/min within 30 days prior to screening. Patient had a stroke or TIA within the last 6 months prior to screening. Patient had a major amputation of the target limb (defined as above the ankle) at the time of screening
Facility Information:
Facility Name
Gefässzentrum Berlin, Evangelisches Krankenhaus KEH
City
Berlin
ZIP/Postal Code
10365
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26245919
Citation
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.
Results Reference
derived

Learn more about this trial

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)

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