Peripheral Artery DiseaseNCT01834495
Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease
A study testing Balloon expandable stent and Self expandable stent in people with Peripheral Artery Disease and Atherosclerosis, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Atherosclerosis
- What is being tested?
- Balloon expandable stent and Self expandable stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2012to 11 Feb 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Clinical criteria:
- symptomatic peripheral-artery disease with
- moderate to severe claudication (Rutherford 2-3),
- chronic critical limb ischemia with pain while was at rest (Rutherford 4),
- or chronic critical limb ischemia with ischemic ulcers (Rutherford 5-6)
- Patients with signed informed consent
Show all 11Show fewer
- 2. Anatomical criteria:
- Target lesion length ≥ 4 cm by angiographic estimation,
- Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,
- Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis),
- At least one patent (less than 50% stenosed) tibioperoneal runoff vessel.
Who cannot join
- Disagree with written informed consent
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agent
- Acute limb ischemia
- Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion)
- Patients that major amputation ("above the ankle" amputation) has been done, is planned or required
- Patients with life expectancy <1 year due to comorbidity
- Age > 85 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Efficacy of Balloon-Expandable Cobalt Chromium SCUBA Stent Versus Self-Expandable Stent COMPLETE-SE Nitinol Stenting for the Atherosclerotic ILIAC Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial
The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.
Read the detailed description
Obstructive atherosclerotic disease of the distal aorta and iliac arteries is preferentially treated with endovascular techniques, and an endovascular-first strategy can be recommended for all TransAtlantic Inter-Society Consensus (TASC) A-C lesions. Low morbidity and mortality as well as a >90% technical success rate justify the endovascular-first approach. Currently, In an attempt to improve outcomes, stent use has increased, and a number of studies favor iliac stenting over simple Percutaneous Transluminal Angioplasty (PTA). A meta-analysis comparing iliac stenting to Percutaneous Transluminal Angioplasty (PTA) found that stenting had higher rates of technical success and was associated with a 39% reduction in the risk of long-term loss of patency.
However, randomized control trial for comparison of primary patency between balloon expandable stent and self expandable stent has not been done, although there were some trials in that primary patency was compared among balloon expandable stents or among self expandable stents.
Currently, The choice of balloon versus self expandable stents is determined mainly by operator preference. The main advantages of balloon expandable stents are the higher radial stiffness and the more accurate placement, which is especially important in bifurcation lesions. In the external iliac artery, a primary stenting strategy using self-expandable stents compared with provisional stenting is preferred mainly due to a lower risk of dissection and elastic recoil.
Thus, the purpose of our study is to examine and compare primary patency between balloon expandable stent and self expandable stent(SCUBA versus COMPLETE SE stent)
- Conditions
- Peripheral Artery Disease, Atherosclerosis
- Being tested
- Balloon expandable stent, Self expandable stent
- Keywords
- Peripheral artery disease, atherosclerosis, stent
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon expandable stentDevice
Also called SCUBA stent
provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
Self expandable stentDevice
Also called COMPLETE SE
provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
| Study group | Role | What they receive |
|---|---|---|
| Balloon expandable stent | Experimental | study design is 1:1 randomization design. Patients will be randomized in a 1:1 manner according to different two (balloon expandable versus Self expandable)stents. Randomization procedure will be performed using a web-based program Receives: Device: Balloon expandable stent |
| Self expandable stent | Active comparator | same to Balloon expandable stent Receives: Device: Self expandable stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
stenosis of at least 50 percent of the luminal diameter in the treated segment 12 months after intervention, as determined by quantitative angiography or CT angiography or peak systolic velocity ratio >2.5 by duplex sonography according to the stent type
Measured: 1year
Secondary outcomes (8)
Clinical outcome
Limb salvage (free of above-the-ankle amputation)
Measured: 1 year
Clinical outcome
Sustained clinical improvement rate at 12 month follow-up
Measured: 1 year
Clinical outcome
Ankle-brachial index (ABI) at 12 months
Measured: 1 year
Clinical outcome
The rate of major adverse cardiovascular events (MACE) at 12 months
Measured: 1 year
Clinical outcome
Repeated target lesion revascularization (TLR) rate
Measured: 1year
Angiographic outcome
Stent fracture rate
Measured: 1 year
Angiographic outcome
Incidence of geographic miss
Measured: 1 year
Clinical outcome
Repeated target extremity revascularization (TER) rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study start28 Oct 2012
- Primary completion31 Jan 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 230 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
- Investigators
- Seung Woon Rha, MD. PhD, Principal investigator, Cardiovascular center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834495
- Sponsor's protocol ID
- SENS-ILIAC
- Status last verified
- Aug 2018
- First submitted
- 8 May 2012
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Choi WG, Rha SW, Choi BG, Park S, Kim JB, Kang DO, Choi CU, Seo YS, Cho YH, Park SH, Lee SJ, Ko YG, Her AY, Kim SM, Kim KC, Cho JH, Kang WY, Kim JH, Kim MW, Kim DH, Bae JH, Ahn JH, Jo SC, Seo JB, Jung WY, Park SM; SENS-ILIAC Investigators. Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial. Heart Vessels. 2024 Dec;39(12):1060-1067. doi: 10.1007/s00380-024-02431-4. Epub 2024 Jul 2.
PubMed 38953938Choi WG, Rha SW, Choi CU, Kim EJ, Oh DJ, Cho YH, Park SH, Lee SJ, Hur AY, Ko YG, Park SM, Kim KC, Kim JH, Kim MW, Kim SM, Bae JH, Bong JM, Kang WY, Seo JB, Jung WY, Cho JH, Kim do H, Ahn JH, Kim SH, Jang JY; SENS-ILIAC Investigators. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial. Trials. 2016 Jun 25;17(1):302. doi: 10.1186/s13063-016-1435-9.
PubMed 27344435
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
- Phase 4 Study of Efficacy of Balloon-Expandable Cobalt Chromium SCUBA Stent Versus Self-Expandable Stent COMPLETE-SE Nitinol Stenting for the Atherosclerotic ILIAC Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01834495
- Acronym / sponsor ID
- SENS-ILIAC
- Conditions
- Peripheral Artery Disease, Atherosclerosis
- Keywords
- Peripheral artery disease, atherosclerosis, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 28 Oct 2012 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 18 Apr 2013 (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 purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.
Detailed description
Obstructive atherosclerotic disease of the distal aorta and iliac arteries is preferentially treated with endovascular techniques, and an endovascular-first strategy can be recommended for all TransAtlantic Inter-Society Consensus (TASC) A-C lesions. Low morbidity and mortality as well as a >90% technical success rate justify the endovascular-first approach. Currently, In an attempt to improve outcomes, stent use has increased, and a number of studies favor iliac stenting over simple Percutaneous Transluminal Angioplasty (PTA). A meta-analysis comparing iliac stenting to Percutaneous Transluminal Angioplasty (PTA) found that stenting had higher rates of technical success and was associated with a 39% reduction in the risk of long-term loss of patency.
However, randomized control trial for comparison of primary patency between balloon expandable stent and self expandable stent has not been done, although there were some trials in that primary patency was compared among balloon expandable stents or among self expandable stents.
Currently, The choice of balloon versus self expandable stents is determined mainly by operator preference. The main advantages of balloon expandable stents are the higher radial stiffness and the more accurate placement, which is especially important in bifurcation lesions. In the external iliac artery, a primary stenting strategy using self-expandable stents compared with provisional stenting is preferred mainly due to a lower risk of dissection and elastic recoil.
Thus, the purpose of our study is to examine and compare primary patency between balloon expandable stent and self expandable stent(SCUBA versus COMPLETE SE stent)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon expandable stent | Experimental | Device: Balloon expandable stentstudy design is 1:1 randomization design. Patients will be randomized in a 1:1 manner according to different two (balloon expandable versus Self expandable)stents. Randomization procedure will be performed using a web-based program |
| Self expandable stent | Active comparator | Device: Self expandable stentsame to Balloon expandable stent |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- symptomatic peripheral-artery disease with
- Patients with signed informed consent
- Target lesion length ≥ 4 cm by angiographic estimation,
- Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,
- Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis),
Key exclusion criteria (8 listed)
- Disagree with written informed consent
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agent
- Acute limb ischemia
- Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion)
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 |
|---|---|---|
| Balloon expandable stentAlso: SCUBA stentprovisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection | Device | Balloon expandable stent |
| Self expandable stentAlso: COMPLETE SEprovisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection | Device | Self expandable stent |
Primary outcome
Primary patency rate
Time frame: 1year
stenosis of at least 50 percent of the luminal diameter in the treated segment 12 months after intervention, as determined by quantitative angiography or CT angiography or peak systolic velocity ratio >2.5 by duplex sonography according to the stent type
8 secondary outcomes
Clinical outcome
Time frame: 1 year
Clinical outcome
Time frame: 1 year
Clinical outcome
Time frame: 1 year
Clinical outcome
Time frame: 1 year
Clinical outcome
Time frame: 1year
Angiographic outcome
Time frame: 1 year
Angiographic outcome
Time frame: 1 year
Clinical outcome
Time frame: 1 year
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.
- Derived from this study: PubMed 38953938Choi WG, Rha SW, Choi BG, Park S, Kim JB, Kang DO, Choi CU, Seo YS, Cho YH, Park SH, Lee SJ, Ko YG, Her AY, Kim SM, Kim KC, Cho JH, Kang WY, Kim JH, Kim MW, Kim DH, Bae JH, Ahn JH, Jo SC, Seo JB, Jung WY, Park SM; SENS-ILIAC Investigators. Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial. Heart Vessels. 2024 Dec;39(12):1060-1067. doi: 10.1007/s00380-024-02431-4. Epub 2024 Jul 2.
- Derived from this study: PubMed 27344435Choi WG, Rha SW, Choi CU, Kim EJ, Oh DJ, Cho YH, Park SH, Lee SJ, Hur AY, Ko YG, Park SM, Kim KC, Kim JH, Kim MW, Kim SM, Bae JH, Bong JM, Kang WY, Seo JB, Jung WY, Cho JH, Kim do H, Ahn JH, Kim SH, Jang JY; SENS-ILIAC Investigators. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial. Trials. 2016 Jun 25;17(1):302. doi: 10.1186/s13063-016-1435-9.
- Individual participant dataSharing planned: No
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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.
Seung Woon Rha, MD. PhD principal investigator
Cardiovascular center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon expandable stent and Self expandable stent in people with Peripheral Artery Disease and Atherosclerosis, 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 11 inclusion and 8 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?
Primary patency rate (time frame: 1year). 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 NCT01834495, which also lists 2 linked publications.
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.