Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire (SPOMCIDGW)

December 11, 2024 updated by: DemaxGroup

Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire

The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hui Wang, 022-58700200
  • Phone Number: 022-58700200
  • Email: zhangxf@demax.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age is 18 years old or older
  2. Written consent to participate in the study
  3. All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.

  4. Eligible for catheter-based diagnostic or treatment procedure. A representative list of diseases and catheter-based treatments includes:

    Suspicion of obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing Suspicion of peripheral vascular obstructive disease undergoing elective or urgent diagnostic and/or percutaneous therapeutic procedures.

  5. Palpable pulse of the proximal and distal radial artery on one or both arms
  6. Subjects must be suitable for a transfemoral vascular access
  7. Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
  8. Subjects with suspected narrowed or blocked arteries in the heart.

Exclusion Criteria:

  1. Inability to provide consent
  2. Pregnant or lactating women
  3. Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
  4. Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
  5. Subject has a known allergy to the Guide Wire materials
  6. Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.
  7. Subjects with severe infections
  8. Subjects with severe heart failure
  9. Subjects with severe physical weakness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Demax Guide Wire
The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vasculature or coronary vasculature disease.
Device: Guide wire
Insert the distal end of the guide wire into the introducer sheath and enter the blood vessel through the introducer sheath;5.Insert the catheter directly into the blood vessel through the guide wire, and when the catheter reaches the target position, exit the guide wire.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: up to 15 ± 2 days after the procedure.
Freedom from SADEs during the procedure and up to 15 ± 2 days after the procedure.
up to 15 ± 2 days after the procedure.
Primary Performance Endpoint
Time Frame: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
Successful introduction of Guide Wire and deployment of the intended diagnostic or therapeutic catheter according to the IFU, without any device related deficiencies per insertion attempt
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Guide Wire deficiencies;
Time Frame: 15 ± 2 days after the procedure
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. In regard to guide wire deficiencies, once captured, we will compare the rate of guide wire deficiencies to the rates of occurrence outlined within the risk management file to see if they match. If the Guidewire deficiencies are over what is found in the risk management file this could lead to a change in risk mitigation.
15 ± 2 days after the procedure
Rate of complications:
Time Frame: 15 ± 2 days after the procedure
Air embolism, Arteriovenous fistula, Infection, Ischemia, Death, Myocardial infarction, Perforation of the vessel wall, Hematoma at the puncture site, Stroke or system embolization, Thrombus formation, Vascular dissection, Vasospasm
15 ± 2 days after the procedure
Expected number of insertion attempts for a single Guide Wire to reach primary performance endpoint
Time Frame: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
It is designed to capture the total number of insertion attempts, it can only be qualitative due each procedure being different. Variables for each procedure include (but not limited) the following: Clinical condition of patient, product type used, point of entry site, skill of user.
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
Expected time to reach the specified position with the Guide Wire
Time Frame: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
It is designed to consider the subjective nature of time taken during the procedure, it can only be qualitative due each procedure being different. Variables for each procedure include (but not limited) the following: Clinical condition of patient, product type used, point of entry site, skill of user.
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DemaxGroup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMK/QS-QP32-QD03.15-TJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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