AtherosclerosisNCT02840786
Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
A study testing plaque excision system and balloon and Stent in people with Atherosclerosis and Ischemia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (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, Ischemia
- What is being tested?
- plaque excision system and balloon and Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). 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.
About this study
Official title: Occlusive Disease of Lower Extremity
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
Read the detailed description
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
- Conditions
- Atherosclerosis, Ischemia
- Being tested
- plaque excision system, balloon and Stent
- Keywords
- stents, atherectomy, femoral artery, popliteal artery
- Medical subject headings
- Atherosclerosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plaque excision systemDevice
balloon and StentDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Stents | Active comparator | Stents group Receives: Device: balloon and Stent |
| Intervention: Atherectomy | Active comparator | directional atherectomy group Receives: Device: plaque excision system |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Primary Patency Rate
systolic velocity ratio >2.4 as measured by Duplex ultrasound.
Measured: 12 months
Secondary outcomes (4)
Technical success
Technical success was 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 thefreedom from clinically-driven target lesion revascularization
Measured: 12 months
Major Adverse Events at 12-month Post Procedure
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
12-month 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 posted21 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Chao Yang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840786
- Sponsor's protocol ID
- XuanwuH16
- Status last verified
- Apr 2016
- First submitted
- 19 Jul 2016
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
- Occlusive Disease of Lower Extremity
- ClinicalTrials.gov ID
- NCT02840786
- Acronym / sponsor ID
- XuanwuH16
- Conditions
- Atherosclerosis, Ischemia
- Keywords
- stents, atherectomy, femoral artery, popliteal artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Chao Yang Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 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 and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
Detailed description
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Stents | Active comparator | Device: balloon and StentStents group |
| Intervention: Atherectomy | Active comparator | Device: plaque excision systemdirectional atherectomy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
| balloon and Stent | Device | Intervention: Stents |
Primary outcome
12-month Primary Patency Rate
Time frame: 12 months
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 at 12-month Post Procedure
Time frame: 12 months
12-month Limb Salvage 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 4 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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 plaque excision system and balloon and Stent in people with Atherosclerosis and Ischemia, 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?
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 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?
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?
12-month 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?
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.