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

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: Not yet recruiting
• Conditions: Coronary Artery Disease; Peripheral Vascular Diseases
• Intervention / Treatment: Device: Guide wire

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Wang, 022-58700200; Phone Number: 022-58700200; Email: zhangxf@demax.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	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	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

Outcome Measure	Measure Description	Time Frame
Rate of Guide Wire deficiencies;	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:	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	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	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

• Sponsor: DemaxGroup

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Vascular Diseases; Peripheral Arterial Disease; Coronary Artery Disease; Peripheral Vascular Diseases
• Other Study ID 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