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

NCT06735846 | Not Yet Recruiting

• 1 other identifier: DMK/QS-QP32-QD03.15-TJ
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Vascular Diseases; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rate of Guide Wire deficiencies;

  15 ± 2 days after the procedure

• Rate of complications:

  15 ± 2 days after the procedure

• Expected number of insertion attempts for a single Guide Wire to reach primary performance endpoint

  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

  Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)

Study Arms (1)

Demax Guide Wire

EXPERIMENTAL

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

Interventions

Guide wire DEVICE

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.

Demax Guide Wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is 18 years old or older
• Written consent to participate in the study
• All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.
• 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.
• Palpable pulse of the proximal and distal radial artery on one or both arms
• Subjects must be suitable for a transfemoral vascular access
• Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
• Subjects with suspected narrowed or blocked arteries in the heart.

You may not qualify if:

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

Sponsors & Collaborators

• DemaxGroup: lead

MeSH Terms

Conditions

Peripheral Vascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Hui Wang, 022-58700200

CONTACT

022-58700200; zhangxf@demax.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: December 16, 2024
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12