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Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Debulking Atherectomy
Stent Angioplasty
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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%) Exclusion Criteria: 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 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

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
  • China-Japan Union Hospital, Jilin UniversityRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Zhongshan Hospital of Fudan UniversityRecruiting
  • Shanghai Pudong Hospital, Fudan UniversityRecruiting
  • Shanxi Bethune hospitalRecruiting
  • First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Debulking Atherectomy

Stent Angioplasty

Arm Description

Excimer laser atherectomy combined with drug-coated balloon angioplasty

Nickel-titanium self-expanding bare stent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical success
Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30%
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.
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)
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)
Rutherford grades at 6 and 12 months postoperatively
Rutherford grades at 6 and 12 months postoperatively
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
The number of days of hospitalization
The number of days of hospitalization
The cost of hospitalization
The cost of hospitalization

Full Information

First Posted
December 4, 2022
Last Updated
January 2, 2023
Sponsor
Xuanwu Hospital, Beijing
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
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1. Study Identification

Unique Protocol Identification Number
NCT05670171
Brief Title
Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Debulking Atherectomy
Arm Type
Active Comparator
Arm Description
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Arm Title
Stent Angioplasty
Arm Type
Active Comparator
Arm Description
Nickel-titanium self-expanding bare stent
Intervention Type
Procedure
Intervention Name(s)
Debulking Atherectomy
Intervention Description
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Intervention Type
Procedure
Intervention Name(s)
Stent Angioplasty
Intervention Description
Nickel-titanium self-expanding bare stent
Primary Outcome Measure Information:
Title
Clinical-driven revascularization rate of target lesions 12-months after surgery
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success
Description
Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30%
Time Frame
Intraoperative
Title
Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery
Description
Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up.
Time Frame
12 months
Title
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
Description
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
Time Frame
12 months
Title
Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Description
Wagnar grade changes diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Time Frame
6 months and 12 months
Title
Rutherford grades at 6 and 12 months postoperatively
Description
Rutherford grades at 6 and 12 months postoperatively
Time Frame
6 months and 12 months
Title
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Description
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Time Frame
6 months and 12 months
Title
The number of days of hospitalization
Description
The number of days of hospitalization
Time Frame
1 month
Title
The cost of hospitalization
Description
The cost of hospitalization
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
The incidence of surgery-related complications within 30 days after surgery
Description
Including arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation.
Time Frame
30 days
Title
All adverse events and serious adverse events were recorded during the study period.
Description
All adverse events and serious adverse events were recorded during the study period.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%) Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Gu, MD
Phone
+8615901598209
Email
gu15901598209@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Guo, MD
Phone
+8613146369562
Email
guojianming@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongquan Gu, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongquan Gu, MD
Phone
15901598209
Email
gu15901598209@aliyun.com
Facility Name
The Second Hospital of Hebei Medical University
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Bi, MD
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Li, MD
Facility Name
China-Japan Union Hospital, Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianshi Du, MD
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingjin Guo
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Dong, MD
Facility Name
Shanghai Pudong Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201399
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingdong Tang, MD
Facility Name
Shanxi Bethune hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Hao, MD
Facility Name
First Affiliated Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoying Lu, MD
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen, Dai

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.

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