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

NCT ID: NCT06735846

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Guide wire

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DemaxGroup

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hui Wang, 022-58700200

Role: CONTACT

Phone: 022-58700200

Email: zhangxf@demax.cn

Other Identifiers

DMK/QS-QP32-QD03.15-TJ

Identifier Type: -

Identifier Source: org_study_id