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

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

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

NCT06735846•DemaxGroup

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

March 1, 2025

Primary Completion Date

June 1, 2025

Completion Date

July 1, 2025

Last Updated

December 16, 2024

Enrollment

100

ESTIMATED participants

Conditions

Peripheral Vascular DiseasesCoronary Artery Disease

Interventions

Guide wire

DEVICE

Contacts

Hui Wang, 022-58700200

CONTACT

022-58700200 zhangxf@demax.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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