Back to resultsUse of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Interlocking detachable coils system
Interlock Fibered IDC Occlusion System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 years;
- Subject diagnosed with peripheral arterial embolization by preoperative imaging (CTA);
- The target vessel can be embolized in one operation;
- The visual diameter of the target blood vessel is 5mm-30mm;
- Subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.
Exclusion Criteria:
- Definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics;
- Definite allergy to platinum, tungsten and/or any substance in the test coil;
- Subjects are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders (such as hemophilia);
- The target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months;
- The target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease;
- Women who are pregnant or breastfeeding;
- Subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial;
- The researcher believes that it is not suitable to participate in the trial.
Sites / Locations
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A Interlocking detachable coils system
group B Interlock Fibered IDC Occlusion System
Arm Description
The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions.
The coil adopts the design of mechanical release, and can be recovered, repositioned and released at any time when the release process meets certain conditions.
Outcomes
Primary Outcome Measures
target vessel occlusion rate
no blood flow through the occluded segment of the target vessel
Secondary Outcome Measures
Full Information
NCT ID
NCT05391399
First Posted
May 22, 2022
Last Updated
May 22, 2022
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05391399
Brief Title
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Official Title
A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of interlocking detachable coils system in the treatment of Chinese patients with embolization of peripheral arterial in comparison with Interlock Fibered IDC Occlusion System
Detailed Description
This is a prospective, multicenter, open-label, non-inferiority, randomized controlled clinical trial. The plan is to recruit patients with peripheral arterial disease requiring embolization and then perform peripheral arterial embolization based on randomization using devices in the experimental group or control group. This trail will be conducted in a number of experimental institutions in China, and a total of 116 subjects are planned to be enrolled. All subjects were treated with the interlocking detachable coils system and were evaluated during surgery and before discharge from the treatment of experimental or control devices, followed up at 1 month, 3 months, and 6 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A Interlocking detachable coils system
Arm Type
Experimental
Arm Description
The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions.
Arm Title
group B Interlock Fibered IDC Occlusion System
Arm Type
Active Comparator
Arm Description
The coil adopts the design of mechanical release, and can be recovered, repositioned and released at any time when the release process meets certain conditions.
Intervention Type
Device
Intervention Name(s)
Interlocking detachable coils system
Intervention Description
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
Intervention Type
Device
Intervention Name(s)
Interlock Fibered IDC Occlusion System
Intervention Description
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
Primary Outcome Measure Information:
Title
target vessel occlusion rate
Description
no blood flow through the occluded segment of the target vessel
Time Frame
6 months
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:
Age 18-80 years;
Subject diagnosed with peripheral arterial embolization by preoperative imaging (CTA);
The target vessel can be embolized in one operation;
The visual diameter of the target blood vessel is 5mm-30mm;
Subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.
Exclusion Criteria:
Definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics;
Definite allergy to platinum, tungsten and/or any substance in the test coil;
Subjects are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders (such as hemophilia);
The target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months;
The target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease;
Women who are pregnant or breastfeeding;
Subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial;
The researcher believes that it is not suitable to participate in the trial.
Facility Information:
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
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