Patients With Symptomatic Critical Limb IschemiaPhase 4EXPANDNCT00906022
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)
A Phase 4 study testing Astron Pulsar Stent and PTA alone in people with Patients With Symptomatic Critical Limb Ischemia and Severe Intermittent Claudication, run by Biotronik AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
- What is being tested?
- Astron Pulsar Stent and PTA alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Gefässzentrum Berlin, Evangelisches Krankenhaus KEH
Berlin, 10365
About this study
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.
- Being tested
- Astron Pulsar Stent, PTA alone
- Keywords
- Below the Knee, Infrapopliteal arteries, nitinol, limb ischemia, claudication, self-expanding stent, duplex, angiography
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astron Pulsar StentDevice
Stenting with Astron Pulsar
PTA aloneDevice
Balloon angioplasty alone
| Study group | Role | What they receive |
|---|---|---|
| Astron Pulsar Stent | Experimental | Device: Astron Pulsar Stent Receives: Device: Astron Pulsar Stent |
| PTA alone | Active comparator | Device: Balloon angioplasty alone Receives: Device: PTA alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Symptomatic Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906022
- Sponsor's protocol ID
- C0801
- Acronym
- EXPAND
- Status last verified
- Feb 2015
- First submitted
- 20 May 2009
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26245919
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00906022
- Acronym / sponsor ID
- EXPAND / C0801
- Keywords
- Below the Knee, Infrapopliteal arteries, nitinol, limb ischemia, claudication, self-expanding stent, duplex, angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astron Pulsar Stent | Experimental | Device: Astron Pulsar StentDevice: Astron Pulsar Stent |
| PTA alone | Active comparator | Device: PTA aloneDevice: Balloon angioplasty alone |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astron Pulsar StentStenting with Astron Pulsar | Device | Astron Pulsar Stent |
| PTA aloneBalloon angioplasty alone | Device | PTA alone |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Derived from this study: PubMed 26245919Schulte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Astron Pulsar Stent and PTA alone in people with Patients With Symptomatic Critical Limb Ischemia and Severe Intermittent Claudication, run by Biotronik AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.