Critical Limb IschemiaNCT04365075
Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.
A study testing Excimer Laser Combined with DCB and Angioplasty Alone in people with Critical Limb Ischemia and Infrapopliteal Lesions, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Infrapopliteal Lesions
- What is being tested?
- Excimer Laser Combined with DCB and Angioplasty Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- 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
- The treatment vessel is DeNovo
- Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
- Reference target vessel diameter between 2-4.0 mm by visual assessment
- Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
- The patient must be >18 years of age
- Life-expectancy of more than 12 months
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- The patient has no child bearing potential or negative serum pregnancy test
- within 7 days of the index procedure
- The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
- The patient must provide written patient informed consent that is approved by the ethics committee
- Anatomic Inclusion Criteria:
- All inflow lesions successfully (<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
- At least one angiographically visible target at the ankle for establishment of straight line flow.
Who cannot join
- Patient refusing treatment
- The target vessel segment diameter is not suitable for available catheter design.
- Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
- Lesion lies within or adjacent to an aneurysm
- The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
- The patient has a history of prior life-threatening contrast media reaction.
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- The patient is currently enrolled in another investigational device or drug trial.
- The patient is currently breast-feeding, pregnant or intends to become pregnant.
- The patient is unable to provide informed consent
- The patient has end stage renal disease (currently on any form of dialysis)
- Known Left Ventricular Ejection Fraction < 35%
- The patient has had a myocardial ischemia within 30 days prior to enrollment
- The patient has had a cardiovascular accident within 90 days prior to enrollment
- Serum Creatinine > 150 µmol
- The patient has a previous bypass in the target limb
- The patient has a current systemic infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongquan Gu
Beijing, Beijing Municipality, 100053
jianming guo, M.D., 13146369562, guojianming@aliyun.com
About this study
Official title: Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.
This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
Read the detailed description
This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
- Conditions
- Critical Limb Ischemia, Infrapopliteal Lesions
- Being tested
- Excimer Laser Combined with DCB, Angioplasty Alone
- Keywords
- Excimer Laser, Angioplasty, drug-coated baloons
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer Laser Combined with DCBDevice
Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
Angioplasty AloneDevice
Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Excimer Laser Combined with DCB | Experimental | Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia. Receives: Device: Excimer Laser Combined with DCB |
| Angioplasty Alone | Active comparator | Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia. Receives: Device: Angioplasty Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion revascularization rate
Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.
Measured: 6-months
Secondary outcomes (8)
Incidence of major adverse events
Incidence of major adverse events (including operative-related arterial dissection, perforation, rupture, embolization, acute thrombosis, pseudoaneurysm, and hematoma formation).
Measured: 6-months
Major amputation rate
The rate of major amputation.
Measured: 6-months
Mortality
The ratio of deaths
Measured: 6-months
Ankle Brachial Index
Measured: 6-months
transcutaneous oxygen pressure
Measured: 6-months
Wound healing wagner score (for patients with Rutherford classification 5)
Wound healing wagner score (for patients with Rutherford classification 5).
Measured: 6-months
Length of hospital stay
Measured: 6-months
hospitalization costs
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- 184 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
- NCT04365075
- Sponsor's protocol ID
- XuanwuH202001
- Status last verified
- Oct 2022
- First submitted
- 24 Apr 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.
- ClinicalTrials.gov ID
- NCT04365075
- Acronym / sponsor ID
- XuanwuH202001
- Conditions
- Critical Limb Ischemia, Infrapopliteal Lesions
- Keywords
- Excimer Laser, Angioplasty, drug-coated baloons
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Apr 2020 (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 study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
Detailed description
This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excimer Laser Combined with DCB | Experimental | Device: Excimer Laser Combined with DCBUsing excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia. |
| Angioplasty Alone | Active comparator | Device: Angioplasty AloneUsing angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The treatment vessel is DeNovo
- Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
- Reference target vessel diameter between 2-4.0 mm by visual assessment
- Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
- The patient must be >18 years of age
Key exclusion criteria (16 listed)
- Patient refusing treatment
- The target vessel segment diameter is not suitable for available catheter design.
- Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
- Lesion lies within or adjacent to an aneurysm
- The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
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 |
|---|---|---|
| Excimer Laser Combined with DCBUsing excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia. | Device | Excimer Laser Combined with DCB |
| Angioplasty AloneUsing angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia. | Device | Angioplasty Alone |
Primary outcome
Target lesion revascularization rate
Time frame: 6-months
Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.
8 secondary outcomes
Incidence of major adverse events
Time frame: 6-months
Major amputation rate
Time frame: 6-months
Mortality
Time frame: 6-months
Ankle Brachial Index
Time frame: 6-months
transcutaneous oxygen pressure
Time frame: 6-months
Wound healing wagner score (for patients with Rutherford classification 5)
Time frame: 6-months
Length of hospital stay
Time frame: 6-months
hospitalization costs
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer Laser Combined with DCB and Angioplasty Alone in people with Critical Limb Ischemia and Infrapopliteal Lesions, 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 13 inclusion and 16 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 12 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianming guo, M.D. (13146369562, guojianming@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion revascularization rate (time frame: 6-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 12 Oct 2022.