Peripheral Arterial DiseaseNCT05391399

Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization

A study testing Interlocking detachable coils system and Interlock Fibered IDC Occlusion System in people with Peripheral Arterial Disease, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Interlocking detachable coils system and Interlock Fibered IDC Occlusion System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteChina
Study dates: 29 Apr 2019to 19 Jul 2021
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial

Read the 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.

Conditions: Peripheral Arterial Disease
Being tested: Interlocking detachable coils system, Interlock Fibered IDC Occlusion System
Keywords: Peripheral Arterial Disease
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.

Interlocking detachable coils systemDevice
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
Interlock Fibered IDC Occlusion SystemDevice
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

Study groups in NCT05391399
Study group	Role	What they receive
group A Interlocking detachable coils system	Experimental	The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions. Receives: Device: Interlocking detachable coils system
group B Interlock Fibered IDC Occlusion System	Active comparator	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. Receives: Device: Interlock Fibered IDC Occlusion System

What is being measured

The primary outcome is the main question the study is designed to answer.

target vessel occlusion rate
no blood flow through the occluded segment of the target vessel
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 201919 Jul 2021

First posted26 May 2022
Study start29 Apr 2019
Primary completion19 Jul 2021
Study completion19 Jul 2021

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.
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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05391399
Sponsor's protocol ID: CP01-025A
Status last verified: May 2022
First submitted: 22 May 2022
Last updated: 26 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
ClinicalTrials.gov ID: NCT05391399
Acronym / sponsor ID: CP01-025A
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
Study start: 29 Apr 2019 (actual)
Primary completion: 19 Jul 2021 (actual)
Study completion: 19 Jul 2021 (actual)
First posted: 26 May 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group A Interlocking detachable coils system	Experimental	Device: Interlocking detachable coils systemThe coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions.
group B Interlock Fibered IDC Occlusion System	Active comparator	Device: Interlock Fibered IDC Occlusion SystemThe coil adopts the design of mechanical release, and can be recovered, repositioned and released at any time when the release process meets certain conditions.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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;

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
Interlocking detachable coils systemMainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.	Device	group A Interlocking detachable coils system
Interlock Fibered IDC Occlusion SystemMainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.	Device	group B Interlock Fibered IDC Occlusion System

Primary outcome

target vessel occlusion rate
Time frame: 6 months
no blood flow through the occluded segment of the target vessel

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target vessel occlusion rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391399.

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 26 May 2022.