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

N/ANot Yet RecruitingNCT06735846

DemaxGroup100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Peripheral Vascular Diseases Coronary Artery Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Safety Endpoint

Freedom from SADEs during the procedure and up to 15 ± 2 days after the procedure.

Time frame: 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

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

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts