Arterial Disease of LegsNCT06211127
Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions
A study testing Cold laser plaque ablation and The excimer laser in people with Arterial Disease of Legs and Atherosclerosis of Artery, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arterial Disease of Legs, Atherosclerosis of Artery
- What is being tested?
- Cold laser plaque ablation and The excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 31 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General selection criteria
- Age between 18 and 85, gender is not limited;
- Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
- The stenosis of lower extremity arteries is greater than 70% or occlusion;
- The subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent.
- Intraoperative contrast inclusion criteria
- The internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm;
- The stenosis of target lesion is greater than 70%;
Who cannot join
- The target lesion is located in the artificial vascular or autologous venous vascular bypass;
- Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure;
- Intent to use other atherectomy device in the same procedure;
- Flow-limiting dissection within, proximal or distal to the target lesion;
- Evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
- Uncorrected coagulation abnormalities (platelet count ≤ 75*109/ L or INR≥2.0), bleeding constitution, and history of heparin-induced thrombocytopenia (HIT);
Show all 13Show fewer
- Any thrombolytic therapy was performed within 2 weeks before surgery;
- History of severe trauma, fracture, major surgery, or parenchymal organ biopsy within 2 weeks before surgery;
- Known allergy to contrast agents or perioperative drugs;
- Anticoagulation, antiplatelet or thrombolytic therapy is prohibited;
- Pregnant or lactating women;
- Subjects participating in other clinical trials of drugs or medical devices;
- Other circumstances assessed by the investigator as inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Lianrui Guo, MD
Xixiang Gao, +8613581674309, vascsurgeon@163.com
About this study
Official title: Assessment the Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions: A Prospective, Multicenter, Randomized Controlled Study.
This study is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia.
Read the detailed description
This study is a prospective, multi-center, randomized controlled study. This study will be conducted at four centers and is expected to enroll 110 patients. And we will evaluate the effectiveness and safety of cold laser plaque ablation compared to excimer laser system for lower limb arterial stenosis and occlusive lesions.
- Being tested
- Cold laser plaque ablation, The excimer laser
- Keywords
- cold laser plaque ablation, lower limb arterial stenosis, occlusive lesions, Atherectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold laser plaque ablationDevice
Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.
The excimer laserDevice
Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cold laser plaque ablation group | Experimental | The disposable cold laser plaque ablation catheter (hereinafter referred to as the ablation catheter) is used in conjunction with the cold laser plaque ablation System), which is suitable for the treatment of arteriosclerosis stenosis and occlusive lesions of the lower limbs. Receives: Device: Cold laser plaque ablation |
| The excimer laser group | Active comparator | Excimer laser uses 308nm wavelength excimer laser to conduct atherosclerotic plaques through the intertwined optical fibers in the catheter, using three action mechanisms of photothermal energy, photochemical energy and acoustic mechanical energy. Receives: Device: The excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual diameter stenosis
Reduction from baseline in residual diameter stenosis (measured in percent), prior to any adjunctive therapy, achieved by the laser catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms.
Measured: 1 month, 6 months after surgery
Secondary outcomes (9)
Secondary effectiveness evaluating indicator:1）Primary patency rate
Proportion of patients with residual vessel diameter greater than 30% within 1 month and 6 months
Measured: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels
Proportion of patients requiring reoperation for revascularization within 1 month and 6 months due to recurrence or worsening of symptoms caused by the original diseased vessel
Measured: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:3）Rutherford grade
Rutherford classification can effectively evaluate the blood supply of patients' lower limbs
Measured: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:4）Ankle-brachial index
Ankle-brachial index is generally the ratio of ankle systolic blood pressure to brachial artery systolic blood pressure. Ankle-brachial index is a test method to objectively determine the severity of limb ischemia
Measured: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:5)Instrument performance evaluation
Differences in the ablation effects of cold laser and excimer laser on lesions of different nature (thrombus, calcified plaque)
Measured: 1 month
safety evaluating indicator:1) Major Adverse Event (MAE)
Including limb amputation and death due to inversion of diseased blood vessels
Measured: 1 month, 6 months after surgery
safety evaluating indicator:2）Device-associated composite endpoint (Do CE)
Intraoperative device-induced distal embolization or postoperative vascular occlusion
Measured: 1 month
safety evaluating indicator:3）Adverse events / Serious adverse events (AE / SAE)
Adverse events of perforation, dissection, and postoperative hematoma
Measured: 1 month, 6 months after surgery
safety evaluating indicator:4）Incidence of device defects
For example, lesions in certain specific parts cannot be completely removed, etc.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start16 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Disease of LegsStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
- Investigators
- Lianrui Guo, M.D., Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211127
- Sponsor's protocol ID
- ZKRG-PAD-202304
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions: A Prospective, Multicenter, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06211127
- Acronym / sponsor ID
- ZKRG-PAD-202304
- Keywords
- cold laser plaque ablation, lower limb arterial stenosis, occlusive lesions, Atherectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (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 is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia.
Detailed description
This study is a prospective, multi-center, randomized controlled study. This study will be conducted at four centers and is expected to enroll 110 patients. And we will evaluate the effectiveness and safety of cold laser plaque ablation compared to excimer laser system for lower limb arterial stenosis and occlusive lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold laser plaque ablation group | Experimental | Device: Cold laser plaque ablationThe disposable cold laser plaque ablation catheter (hereinafter referred to as the ablation catheter) is used in conjunction with the cold laser plaque ablation System), which is suitable for the treatment of arteriosclerosis stenosis and occlusive lesions of the lower limbs. |
| The excimer laser group | Active comparator | Device: The excimer laserExcimer laser uses 308nm wavelength excimer laser to conduct atherosclerotic plaques through the intertwined optical fibers in the catheter, using three action mechanisms of photothermal energy, photochemical energy and acoustic mechanical energy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General selection criteria
- Age between 18 and 85, gender is not limited;
- Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
- The stenosis of lower extremity arteries is greater than 70% or occlusion;
- The subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent.
Key exclusion criteria (13 listed)
- The target lesion is located in the artificial vascular or autologous venous vascular bypass;
- Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure;
- Intent to use other atherectomy device in the same procedure;
- Flow-limiting dissection within, proximal or distal to the target lesion;
- Evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
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 |
|---|---|---|
| Cold laser plaque ablationPatients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery. | Device | Cold laser plaque ablation group |
| The excimer laserPatients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery. | Device | The excimer laser group |
Primary outcome
residual diameter stenosis
Time frame: 1 month, 6 months after surgery
Reduction from baseline in residual diameter stenosis (measured in percent), prior to any adjunctive therapy, achieved by the laser catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms.
9 secondary outcomes
Secondary effectiveness evaluating indicator:1）Primary patency rate
Time frame: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels
Time frame: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:3）Rutherford grade
Time frame: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:4）Ankle-brachial index
Time frame: 1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:5)Instrument performance evaluation
Time frame: 1 month
safety evaluating indicator:1) Major Adverse Event (MAE)
Time frame: 1 month, 6 months after surgery
safety evaluating indicator:2）Device-associated composite endpoint (Do CE)
Time frame: 1 month
safety evaluating indicator:3）Adverse events / Serious adverse events (AE / SAE)
Time frame: 1 month, 6 months after surgery
safety evaluating indicator:4）Incidence of device defects
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Arterial Disease of Legs
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 4
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Active, not recruitingObservational study
Geko™ Cross Therapy Registry - Wound
Wound, Venous Leg Ulcer
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.
Lianrui Guo, M.D. study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold laser plaque ablation and The excimer laser in people with Arterial Disease of Legs and Atherosclerosis of Artery, 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 8 inclusion and 13 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 18 Jan 2024. 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 Lianrui Guo, M.D. (+8613671009746, lianruiguo@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual diameter stenosis (time frame: 1 month, 6 months after surgery). 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 18 Jan 2024.