Critical Limb IschemiaSENS-BTKNCT01644487
Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)
A study testing self-expanding nitinol stent and balloon angioplasty in people with Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Critical Limb Ischemia, Infrapopliteal Arterial Occlusive Disease
- What is being tested?
- self-expanding nitinol stent and balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to 10 Oct 2018
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic critical limb ischemia (Rutherford 4 - 6)
- Patients with signed informed consent
- Target lesion length < 8 cm by angiographic estimation
- Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
- Reference vessel diameter should be 2.0-4.5 mm
Who cannot join
- Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- Patient takes warfarin
- Patient has a history of previous life-threatening contrast media reaction
- Patient is currently enrolled in another investigational device or drug trial
- Patient is currently breast-feeding, is pregnant, or intends to become pregnant
- Patient is mentally ill or retarded
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- Acute critical limb ischemia
- Major bleeding history within prior 2 months
- Severe hepatic dysfunction (> 3 times normal reference values)
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- Life expectancy <1 year due to comorbidity
- Reference segment diameter is not suitable for available stent design
- Previously implanted stent(s) or PTA at the same lesion site
- Inflow-limiting arterial lesions left untreated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.
Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.
- Being tested
- self-expanding nitinol stent, balloon angioplasty
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-expanding nitinol stentDevice
Also called Xpert stent
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
balloon angioplastyDevice
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
| Study group | Role | What they receive |
|---|---|---|
| Primary stenting | Experimental | A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty Receives: Device: self-expanding nitinol stent |
| Balloon only | Active comparator | A group of patients who will undergo routine conventional balloon angioplasty alone without stenting Receives: Device: balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic binary restenosis rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion6 Sep 2016
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Woon Rha, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644487
- Sponsor's protocol ID
- EV-10302
- Acronym
- SENS-BTK
- Status last verified
- Aug 2017
- First submitted
- 17 Jul 2012
- Last updated
- 14 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)
- ClinicalTrials.gov ID
- NCT01644487
- Acronym / sponsor ID
- SENS-BTK / EV-10302
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 19 Jul 2012 (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 objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.
Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
| Arm | Type | Receives |
|---|---|---|
| Primary stenting | Experimental | Device: self-expanding nitinol stentA group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty |
| Balloon only | Active comparator | Device: balloon angioplastyA group of patients who will undergo routine conventional balloon angioplasty alone without stenting |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic critical limb ischemia (Rutherford 4 - 6)
- Patients with signed informed consent
- Target lesion length < 8 cm by angiographic estimation
- Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
- Reference vessel diameter should be 2.0-4.5 mm
Key exclusion criteria (14 listed)
- Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- Patient takes warfarin
- Patient has a history of previous life-threatening contrast media reaction
- Patient is currently enrolled in another investigational device or drug trial
- Patient is currently breast-feeding, is pregnant, or intends to become pregnant
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 |
|---|---|---|
| self-expanding nitinol stentAlso: Xpert stentA group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty | Device | Primary stenting |
| balloon angioplastyA group of patients who will undergo routine conventional balloon angioplasty alone without stenting | Device | Balloon only |
Primary outcome
Angiographic binary restenosis rate
Time frame: 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 14 Aug 2019.
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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 study testing self-expanding nitinol stent and balloon angioplasty in people with Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease, run by Korea University Guro Hospital at 1 site in South Korea.
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 5 inclusion and 14 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 14 Aug 2019. 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 South Korea. 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.
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?
Angiographic binary restenosis rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2019.