search
Back to results

Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection (PINTO)

Primary Purpose

Peripheral Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the spot stent(ZENFLEX ® Pinto) system
the bare stent( Everflex) system
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18 to 80 years,male or female
  2. Lower extremity atherosclerotic occlusive disease
  3. After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
  4. Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent

Exclusion Criteria:

  1. The target lesion has been stented or previously treated with bypass surgery
  2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
  3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
  4. More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
  5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
  6. Planned amputation on the target limb
  7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
  8. Uncontrollable infections
  9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
  10. Participating in clinical trials of any other drug or medical device and not yet out of the study
  11. Other circumstances not suitable for inclusion as judged by the investigator

Sites / Locations

  • Xuanwu Hospital, Capital Medical University
  • The First Affiliated Hospital of Bengbu Medical College
  • Changzhou First People's Hospital
  • Changzhou Second People's Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • Anhui Provincial Hospital
  • The Second Affiliated Hospital of Nanchang University
  • Nanjing Drum Tower Hospital
  • Affiliated Hospital of Qingdao University
  • Shanghai Ninth People's Hospital
  • Tianjin Medical University General Hospital
  • North Jiangsu People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ZENFLEX ® Pinto

Everflex

Arm Description

subjects using the spot stent(ZENFLEX ® Pinto) system

subjects using the bare stent(Everflex) system

Outcomes

Primary Outcome Measures

primary patency rate at 12 months after operation

Secondary Outcome Measures

success rate of the device
success rate of the technique
rate of CD-TLR
ABI
Rutherford classification
the incidence of major adverse events
the rate of target limb major amputation
the incidence of adverse events
the incidence of SAE
the rate of device defect

Full Information

First Posted
August 15, 2022
Last Updated
September 27, 2022
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05562076
Brief Title
Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
Acronym
PINTO
Official Title
A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device 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
No

5. Study Description

Brief Summary
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ZENFLEX ® Pinto
Arm Type
Experimental
Arm Description
subjects using the spot stent(ZENFLEX ® Pinto) system
Arm Title
Everflex
Arm Type
Active Comparator
Arm Description
subjects using the bare stent(Everflex) system
Intervention Type
Device
Intervention Name(s)
the spot stent(ZENFLEX ® Pinto) system
Intervention Description
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Intervention Type
Device
Intervention Name(s)
the bare stent( Everflex) system
Intervention Description
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Primary Outcome Measure Information:
Title
primary patency rate at 12 months after operation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
success rate of the device
Time Frame
Intraoperation
Title
success rate of the technique
Time Frame
post operation
Title
rate of CD-TLR
Time Frame
6 months,12 months
Title
ABI
Time Frame
post operation, 6 months,12 months
Title
Rutherford classification
Time Frame
post operation, 6 months,12 months
Title
the incidence of major adverse events
Time Frame
30 days, 6 months,12 months
Title
the rate of target limb major amputation
Time Frame
30 days, 6 months,12 months
Title
the incidence of adverse events
Time Frame
Intraoperation, post operation, 30 days, 6 months,12 months
Title
the incidence of SAE
Time Frame
Intraoperation, post operation, 30 days, 6 months,12 months
Title
the rate of device defect
Time Frame
Intraoperation, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 years,male or female Lower extremity atherosclerotic occlusive disease After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F) Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent Exclusion Criteria: The target lesion has been stented or previously treated with bypass surgery Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion Planned amputation on the target limb Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol Uncontrollable infections Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial Participating in clinical trials of any other drug or medical device and not yet out of the study Other circumstances not suitable for inclusion as judged by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jie Liang
Phone
13819565660
Email
jie.liang@zyloxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Li
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianrui Guo
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaowen Yu
Facility Name
Changzhou First People's Hospital
City
Changzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Zhu
Facility Name
Changzhou Second People's Hospital
City
Changzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfeng Zhu
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Liu
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Zhou
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Li
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingjin Guo
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinwu Lu
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai
Facility Name
North Jiangsu People's Hospital
City
Yangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaolei Chen

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection

We'll reach out to this number within 24 hrs