ClaudicationNCT01359423
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
A study testing Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long and short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome. in people with Claudication, run by Yonsei University at 1 site in South Korea.
Trial summary
Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions. Study design : Prospective, randomized, multi-center study A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Claudication
- What is being tested?
- Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long and short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2011to 10 Aug 2017
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical criteria:
- Age 20 years of older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Patients with signed informed consent
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- Anatomical criteria:
- Target lesion length ≥80 mm by angiographic estimation
- Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
- At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
Who cannot join
- Clinical criteria
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
- Age > 85 years
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- Severe hepatic dysfunction (> 3 times normal reference values)
- Significant renal dysfunction (Serum creatinine > 2.0 mg/dl
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- LVEF < 40% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy <1 year due to comorbidity
- Angiographic criteria
- Previous bypass surgery or stenting of the superficial femoral artery
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.
Study design :
- Prospective, randomized, multi-center study
- A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.
- Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.
- Patients will be followed clinically for 1 year after the procedure.
- Angiographic or CT follow-up will be performed at 1 year.
- Conditions
- Claudication
- Being tested
- Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long, short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary longDrug
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.Drug
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
| Study group | Role | What they receive |
|---|---|---|
| long coverage | Experimental | Primary long full coverage stenting Receives: Drug: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long |
| short spot | Active comparator | primary short spot stenting Receives: Drug: short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of binary restenosis
The rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) in the treated segment 12 months after intervention, as determined by computed tomographic angiography (CTA) or catheter angiography according to the stenting strategy
Measured: 12months after the index procedure
Secondary outcomes (1)
Ankle-brachial index, etc
- Ankle-brachial index at 12 months according to the stenting strategy
- Maximal walking distance at 12 months according to the stenting strategy
- The rate of reintervention including repeat endovascular therapy or bypass surgery involving the target lesion
- The rate of limb salvage at 12 months according to the stenting strategy
- The rate of major adverse cardiovascular events (MACE) at 12 months according to the stenting strategy
Measured: at 12 months according to the stenting strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study start26 Sep 2011
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaudicationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359423
- Sponsor's protocol ID
- 1-2010-0065
- Status last verified
- Nov 2017
- First submitted
- 20 May 2011
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
- ClinicalTrials.gov ID
- NCT01359423
- Acronym / sponsor ID
- 1-2010-0065
- Conditions
- Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Sep 2011 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 24 May 2011 (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.
Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.
Study design :
- Prospective, randomized, multi-center study
- A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.
- Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.
- Patients will be followed clinically for 1 year after the procedure.
- Angiographic or CT follow-up will be performed at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long coverage | Experimental | Drug: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary longPrimary long full coverage stenting |
| short spot | Active comparator | Drug: short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.primary short spot stenting |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 20 years of older
- Symptomatic peripheral artery disease:
- Patients with signed informed consent
- Target lesion length ≥80 mm by angiographic estimation
- Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
Key exclusion criteria (15 listed)
- Clinical criteria
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
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 |
|---|---|---|
| Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary longPatients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1. | Drug | long coverage |
| short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1. | Drug | short spot |
Primary outcome
The rate of binary restenosis
Time frame: 12months after the index procedure
The rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) in the treated segment 12 months after intervention, as determined by computed tomographic angiography (CTA) or catheter angiography according to the stenting strategy
1 secondary outcome
Ankle-brachial index, etc
Time frame: at 12 months according to the stenting strategy
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 28 Nov 2017.
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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 Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long and short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome. in people with Claudication, run by Yonsei University 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 10 inclusion and 15 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 28 Nov 2017. 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?
The rate of binary restenosis (time frame: 12months after the index procedure). 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 28 Nov 2017.