AtherosclerosisNCT02832024
Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis
A study testing plaque excision system, stent and Balloon in people with Atherosclerosis and In-stent Arterial Restenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, In-stent Arterial Restenosis
- What is being tested?
- plaque excision system, stent and Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
Who cannot join
- They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits
Trial locations and contacts
1 site in 1 country.
li yang contact
Gu yongquan contact
China1 site, 1 recruiting
- Recruiting
Gu Yong Quan
Beijing, Beijing Municipality, 100053
Yang Li, M.D., 17198643706, liyang0603@aliyun.com
Yong quan Gu, M.D., 15901598209, 15901598209@163.com
About this study
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
Read the detailed description
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
- Conditions
- Atherosclerosis, In-stent Arterial Restenosis
- Being tested
- plaque excision system, stent, Balloon
- Keywords
- stents, atherectomy, femoral artery, popliteal artery, In-stent Restenosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plaque excision systemDevice
stentDevice
BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Stents | Active comparator | Stents group Receives: Device: stent |
| Intervention: Atherectomy | Active comparator | Direct Atherectomy group Receives: Device: plaque excision system |
| Intervention: Balloon | Active comparator | Balloon group Receives: Device: Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate
Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound.
Measured: 12 months
Secondary outcomes (4)
Technical success
Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
Measured: 1 day
freedom from clinically-driven TLR
it is defined as freedom from clinically-driven target lesion revascularization
Measured: 12 months
Major Adverse Events
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
Measured: 12 months
Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
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 posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832024
- Sponsor's protocol ID
- WuanwuH
- Status last verified
- May 2019
- First submitted
- 14 Sep 2015
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.
PubMed 23822938
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis
- ClinicalTrials.gov ID
- NCT02832024
- Acronym / sponsor ID
- WuanwuH
- Conditions
- Atherosclerosis, In-stent Arterial Restenosis
- Keywords
- stents, atherectomy, femoral artery, popliteal artery, In-stent Restenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jul 2016 (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.
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
Detailed description
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention: Stents | Active comparator | Device: stentStents group |
| Intervention: Atherectomy | Active comparator | Device: plaque excision systemDirect Atherectomy group |
| Intervention: Balloon | Active comparator | Device: BalloonBalloon group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
Key exclusion criteria (1 listed)
- They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits
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 |
|---|---|---|
| plaque excision system | Device | Intervention: Atherectomy |
| stent | Device | Intervention: Stents |
| Balloon | Device | Intervention: Balloon |
Primary outcome
Primary Patency Rate
Time frame: 12 months
Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound.
4 secondary outcomes
Technical success
Time frame: 1 day
freedom from clinically-driven TLR
Time frame: 12 months
Major Adverse Events
Time frame: 12 months
Limb Salvage Rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 23822938Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.
- Individual participant dataSharing planned: Yes
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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.
li yang contact
Gu yongquan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plaque excision system, stent and Balloon in people with Atherosclerosis and In-stent Arterial Restenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li yang (17198643706), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency 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?
On the ClinicalTrials.gov record for NCT02832024, 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 4 Dec 2019.