Peripheral Arterial DiseaseNCT05670171
Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
A study testing Debulking Atherectomy and Stent Angioplasty in people with Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 10 sites in China.
Trial summary
In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Debulking Atherectomy and Stent Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 10 sitesChina
- Study dates
- Jan 2023to Dec 2025
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years old
- Rutherford grade 2 to 5
- Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetes
- The target vessel diameter ≥4mm
- The total target length of the lesion is 30-210mm
- The subject is able and willing to comply with all requirements, including 12-month follow-up and evaluation, voluntary participation and informed consen
- Patients with ipsilateral iliac artery inflow tract patency (stenosis ≤50%) or ipsilateral iliac artery inflow tract lesions and successful management (residual stenosis < 30% after treatment, no severe (≥ grade D) flow-limiting dissection , no thrombosis, embolism or other serious adverse events)
- Patients with at least one infrapopliteal artery for patency of the affected lateral foot before or after intraoperative treatment (stenosis ≤50%)
Who cannot join
- Patients with vasculitis or Berger disease
- Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs
- Patients who are allergic to contrast agents and nickel titanium materials
- Patients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgery
- Severe renal dysfunction (creatinine > 221umol/L)
- Patients who received local or systemic thrombolytic therapy within 48 hours before surgery
Show all 21Show fewer
- Patients who had acute myocardial infarction within 30 days before surgery
- Patients who had undergone major surgical procedures (heart, abdominal, or peripheral vascular open surgery) within 30 days before surgery
- Patients who had a stroke within 6 months before surgery
- Patients whose target arteries had received endovascular surgery within 14 days prior to surgery and patients who had other elective surgery plans during the study period
- Patients with end-stage renal disease
- Patients with previous major amputation of the target limb or restenosis after stent or bypass surgery for the target lesion
- Patients with perforation, dissection, or other vascular injury requiring stenting or surgical operation in the approach or target vessel prior to enrollment
- Patients with a life expectancy of < 12 months
- A woman who is pregnant or breastfeeding
- Patients who are participating in clinical trials of other drugs or devices that do not meet trial endpoints
- Patients considered unsuitable for this trial by the investigators Exclusion criteria for angiography
- Patients with severe calcification of the target lesions
- Patients with aneurysms in the target vessels
- Patients with acute or subacute thrombus in the target vessel
- Patients with artificial vessels placed in the limb on the same side of the target vessel
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Yongquan Gu, MD, 15901598209, gu15901598209@aliyun.com
- Recruiting
China-Japan Union Hospital, Jilin University
Changchun, Jilin, 130033
Jianshi Du, MD
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Xiaoqiang Li, MD
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Mingjin Guo
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Zhihui Dong, MD
- Recruiting
Shanghai Pudong Hospital, Fudan University
Shanghai, Shanghai Municipality, 201399
Jingdong Tang, MD
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Wei Bi, MD
- Recruiting
Shanxi Bethune hospital
Taiyuan, Shanxi, 030032
Bin Hao, MD
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Xiangchen, Dai
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Shaoying Lu, MD
About this study
Official title: Assessment the Safety and Efficacy of Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease: A Multicenter, Randomized, Controlled Study.
In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. The main surgical methods included stent angioplasty group (Nickel-titanium self-expanding bare stent) and debulking atherectomy group (Excimer laser atherectomy combined with drug-coated balloon angioplasty). The sample size was 244 patients, and the patients were followed up at 30 days, 180 days, and 365 days after operation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Debulking Atherectomy, Stent Angioplasty
- Keywords
- Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debulking AtherectomyProcedure or surgery
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Stent AngioplastyProcedure or surgery
Nickel-titanium self-expanding bare stent
| Study group | Role | What they receive |
|---|---|---|
| Debulking Atherectomy | Active comparator | Excimer laser atherectomy combined with drug-coated balloon angioplasty Receives: Procedure: Debulking Atherectomy |
| Stent Angioplasty | Active comparator | Nickel-titanium self-expanding bare stent Receives: Procedure: Stent Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical-driven revascularization rate of target lesions 12-months after surgery
Clinically driven revascularization of target lesions was defined as a reduction of ABI ≥20% or >0.15 due to clinical symptoms or compared to the ABI after the initial surgery, any re-interventional therapy required for the target lesion.
Measured: 12 months
Secondary outcomes (8)
Technical success
Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30%
Measured: Intraoperative
Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery
Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up.
Measured: 12 months
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
Measured: 12 months
Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Wagnar grade changes diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Measured: 6 months and 12 months
Rutherford grades at 6 and 12 months postoperatively
Rutherford grades at 6 and 12 months postoperatively
Measured: 6 months and 12 months
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Measured: 6 months and 12 months
The number of days of hospitalization
The number of days of hospitalization
Measured: 1 month
The cost of hospitalization
The cost of hospitalization
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 posted4 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Hospital of Hebei Medical University, Shanxi Bethune Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital of Qingdao University, Shanghai Pudong Hospital, Tianjin Medical University General Hospital, China-Japan Union Hospital, Jilin University, Fudan University
- Responsible party
- Sponsor
- Investigators
- Yongquan Gu, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670171
- Sponsor's protocol ID
- DASALID
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Safety and Efficacy of Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease: A Multicenter, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT05670171
- Acronym / sponsor ID
- DASALID
- Conditions
- Peripheral Arterial Disease
- Keywords
- Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Hospital of Hebei Medical University, Shanxi Bethune Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital of Qingdao University, Shanghai Pudong Hospital, Tianjin Medical University General Hospital, China-Japan Union Hospital, Jilin University, Fudan University
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jan 2023 (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.
In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. The main surgical methods included stent angioplasty group (Nickel-titanium self-expanding bare stent) and debulking atherectomy group (Excimer laser atherectomy combined with drug-coated balloon angioplasty). The sample size was 244 patients, and the patients were followed up at 30 days, 180 days, and 365 days after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debulking Atherectomy | Active comparator | Procedure: Debulking AtherectomyExcimer laser atherectomy combined with drug-coated balloon angioplasty |
| Stent Angioplasty | Active comparator | Procedure: Stent AngioplastyNickel-titanium self-expanding bare stent |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40-80 years old
- Rutherford grade 2 to 5
- Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetes
- The target vessel diameter ≥4mm
- The total target length of the lesion is 30-210mm
Key exclusion criteria (21 listed)
- Patients with vasculitis or Berger disease
- Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs
- Patients who are allergic to contrast agents and nickel titanium materials
- Patients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgery
- Severe renal dysfunction (creatinine > 221umol/L)
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 |
|---|---|---|
| Debulking AtherectomyExcimer laser atherectomy combined with drug-coated balloon angioplasty | Procedure or surgery | Debulking Atherectomy |
| Stent AngioplastyNickel-titanium self-expanding bare stent | Procedure or surgery | Stent Angioplasty |
Primary outcome
Clinical-driven revascularization rate of target lesions 12-months after surgery
Time frame: 12 months
Clinically driven revascularization of target lesions was defined as a reduction of ABI ≥20% or >0.15 due to clinical symptoms or compared to the ABI after the initial surgery, any re-interventional therapy required for the target lesion.
8 secondary outcomes
Technical success
Time frame: Intraoperative
Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery
Time frame: 12 months
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
Time frame: 12 months
Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Time frame: 6 months and 12 months
Rutherford grades at 6 and 12 months postoperatively
Time frame: 6 months and 12 months
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Time frame: 6 months and 12 months
The number of days of hospitalization
Time frame: 1 month
The cost of hospitalization
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 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Yongquan Gu, MD principal investigator
Xuanwu Hospital, Beijing
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debulking Atherectomy and Stent Angioplasty in people with Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 10 sites 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 21 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Yongquan Gu, MD (+8615901598209, gu15901598209@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical-driven revascularization rate of target lesions 12-months after surgery (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 Jan 2023.