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Not yet recruiting NCT06735846

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

No phase Interventional Peripheral Vascular Diseases Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guide wire.
Who it may be relevant to
Registry conditions: Peripheral Vascular Diseases, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: up to 15 ± 2 days after the procedure.]
  • Primary Performance Endpoint [Time frame: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)]
Secondary outcome measures (4)
  • Rate of Guide Wire deficiencies; [Time frame: 15 ± 2 days after the procedure]
  • Rate of complications: [Time frame: 15 ± 2 days after the procedure]
  • Expected number of insertion attempts for a single Guide Wire to reach primary performance endpoint [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 [Time frame: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06735846 · DMK/QS-QP32-QD03.15-TJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗