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DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis (DELTA)

Primary Purpose

Femoral Artery Stenosis, Popliteal Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DKutting LL balloon
Chocolate balloon
Sponsored by
DK Medical Technology (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring PTA Scoring Balloon, Optimal Balloon Angioplasty

Eligibility Criteria

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

Inclusion Criteria: 18-80 year-old male & non-pregnant female Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery. Rutherford clinical category-Becker class: 2 to 5 Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study. Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3. Exclusion Criteria: Acute or sub-acute thrombosis exist in target lesion Severe calcified lesion (PACSS Grading 4) Guidewire cannot cross target lesion Amputation planned within 30 days In-stent restenosis Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment. Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique. Patient who cannot accept anticoagulant or antiplatelet therapy Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics Patients who have not completed clinical trials of other drugs or devices Patients with poor compliance and unable to complete the study, which is identified by investigator.

Sites / Locations

  • The First Affiliated Hospital of Jinan University
  • The First Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • Xiangya Hospital of Central South University
  • Suzhou Municipal Hospital
  • The Affiliated Hospital of Qingdao University
  • Hospital of Chengdu Traditional Chinese Medicine University
  • The Third People's Hospital of Chengdu
  • The Affiliated Hospital of Southwest Medical University
  • China-Japan Friendship Hospital
  • Xuanwu Hospital of Capital Medical University
  • The First Affiliated Hospital of Naval Medical University
  • Zhongshan Hospital of Fudan UniversityRecruiting
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DKutting

Chocolate

Arm Description

DKutting LL Scoring Balloon, DK Medtech Co Ltd

Chocolate Balloon, TriReme Medical LLC

Outcomes

Primary Outcome Measures

Achievement of Optimal PTA in Percent
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-100%, higher the better]

Secondary Outcome Measures

Device Success Rate in Percent
Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. [0-100%, higher the better]
Numerical Acute Lumen Gain in mm
In-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD, as accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-3mm, higher the better]
Technical Success Rate in percent
Percentage of target Lesion achieved <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. [0-100%, higher the better]
Freedom from clinical-driven TLR rate in percent
Freedom from clinical-driven target lesion revascularization 1 month post procedure [0-100%, higher the better]
Rutherford Grading Reduction in percent
Percentage of both groups' patent number, whose Rutherford Grading [0-6, lower is reduced by at least 1 grade post procedure, compared with pre-procedure grade. [0-100%, higher the better]
Freedom from Amputation above ankle rate in percent
Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. [0-100%, higher the better]
Numerical Ankle Brachial Index
Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. [ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people]

Full Information

First Posted
October 21, 2022
Last Updated
November 2, 2022
Sponsor
DK Medical Technology (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05608655
Brief Title
DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
Acronym
DELTA
Official Title
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DK Medical Technology (Suzhou) Co., Ltd.

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
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Detailed Description
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1. Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Artery Stenosis, Popliteal Artery Stenosis
Keywords
PTA Scoring Balloon, Optimal Balloon Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DKutting
Arm Type
Experimental
Arm Description
DKutting LL Scoring Balloon, DK Medtech Co Ltd
Arm Title
Chocolate
Arm Type
Active Comparator
Arm Description
Chocolate Balloon, TriReme Medical LLC
Intervention Type
Device
Intervention Name(s)
DKutting LL balloon
Intervention Description
After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Intervention Type
Device
Intervention Name(s)
Chocolate balloon
Intervention Description
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Primary Outcome Measure Information:
Title
Achievement of Optimal PTA in Percent
Description
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-100%, higher the better]
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Device Success Rate in Percent
Description
Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. [0-100%, higher the better]
Time Frame
1 day
Title
Numerical Acute Lumen Gain in mm
Description
In-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD, as accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-3mm, higher the better]
Time Frame
1 day
Title
Technical Success Rate in percent
Description
Percentage of target Lesion achieved <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. [0-100%, higher the better]
Time Frame
0-7 days
Title
Freedom from clinical-driven TLR rate in percent
Description
Freedom from clinical-driven target lesion revascularization 1 month post procedure [0-100%, higher the better]
Time Frame
30+/-7 Days post procedure
Title
Rutherford Grading Reduction in percent
Description
Percentage of both groups' patent number, whose Rutherford Grading [0-6, lower is reduced by at least 1 grade post procedure, compared with pre-procedure grade. [0-100%, higher the better]
Time Frame
30+/-7 Days post procedure
Title
Freedom from Amputation above ankle rate in percent
Description
Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. [0-100%, higher the better]
Time Frame
30+/-7 Days post procedure
Title
Numerical Ankle Brachial Index
Description
Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. [ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people]
Time Frame
0-7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 year-old male & non-pregnant female Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery. Rutherford clinical category-Becker class: 2 to 5 Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study. Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3. Exclusion Criteria: Acute or sub-acute thrombosis exist in target lesion Severe calcified lesion (PACSS Grading 4) Guidewire cannot cross target lesion Amputation planned within 30 days In-stent restenosis Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment. Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique. Patient who cannot accept anticoagulant or antiplatelet therapy Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics Patients who have not completed clinical trials of other drugs or devices Patients with poor compliance and unable to complete the study, which is identified by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiguo Fu, Dr.
Phone
13801760929
Email
fu.weiguo@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, Dr.
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Dr.
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Liu, Dr.
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Li, Dr.
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, Dr.
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqi Jin, Dr.
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingjin Guo, Dr.
Facility Name
Hospital of Chengdu Traditional Chinese Medicine University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunshui He, Dr.
Facility Name
The Third People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Cui, Dr.
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu, Dr.
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhidong Ye, Dr.
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianrui Guo, Dr.
Facility Name
The First Affiliated Hospital of Naval Medical University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Bao, Dr.
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, Dr.
Phone
13801760929
Email
fu.weiguo@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, Dr.
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai, Dr.

12. IPD Sharing Statement

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DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

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