AtherosclerosisNCT05575245
Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
A study testing Drug-eluting Stent and Excimer Laser Ablation Combined Drug-coated Balloon in people with Atherosclerosis and Ischemia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. 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?
- Drug-eluting Stent and Excimer Laser Ablation Combined Drug-coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2022to 20 Oct 2024
- 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
Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.
Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.
Read the detailed description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
- Conditions
- Atherosclerosis, Ischemia
- Being tested
- Drug-eluting Stent, Excimer Laser Ablation Combined Drug-coated Balloon
- Keywords
- drug-eluting stent, debulking, femoral artery, drug-coated balloon
- Medical subject headings
- Atherosclerosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting StentDevice
Drug-eluting Stent angioplasty
Excimer Laser Ablation Combined Drug-coated BalloonDevice
Excimer Laser Ablation Combined Drug-coated Balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Drug-eluting Stent | Active comparator | Drug-eluting Stent group Receives: Device: Drug-eluting Stent |
| Intervention: Excimer Laser Ablation Combined Drug-coated Balloon | Experimental | Excimer Laser Ablation Combined Drug-coated Balloon group Receives: Device: Excimer Laser Ablation Combined Drug-coated Balloon |
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
Measured: 1 day
freedom from clinically-driven TLR
it is defined as the freedom from clinically-driven target lesion revascularization
Measured: 1 day
Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation,
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 posted12 Oct 2022
- Study start3 Mar 2022
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Why it stopped: The research fund has not yet arrived.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575245
- Sponsor's protocol ID
- XuanwuH135
- Status last verified
- Dec 2022
- First submitted
- 10 Aug 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
- ClinicalTrials.gov ID
- NCT05575245
- Acronym / sponsor ID
- XuanwuH135
- Conditions
- Atherosclerosis, Ischemia
- Keywords
- drug-eluting stent, debulking, femoral artery, drug-coated balloon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research fund has not yet arrived.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 12 Oct 2022 (actual)
- 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 Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.
Detailed description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Drug-eluting Stent | Active comparator | Device: Drug-eluting StentDrug-eluting Stent group |
| Intervention: Excimer Laser Ablation Combined Drug-coated Balloon | Experimental | Device: Excimer Laser Ablation Combined Drug-coated BalloonExcimer Laser Ablation Combined Drug-coated Balloon 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 |
|---|---|---|
| Drug-eluting StentDrug-eluting Stent angioplasty | Device | Intervention: Drug-eluting Stent |
| Excimer Laser Ablation Combined Drug-coated BalloonExcimer Laser Ablation Combined Drug-coated Balloon angioplasty | Device | Intervention: Excimer Laser Ablation Combined Drug-coated Balloon |
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: 1 day
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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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 Drug-eluting Stent and Excimer Laser Ablation Combined Drug-coated Balloon 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: withdrawn, as of the sponsor's last update on 7 Dec 2022. 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 was withdrawn before enrolling participants, so there are no results.
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 7 Dec 2022.