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Completed

NCT Number: NCT05747287

Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Shijiazhuang People's Hospital, Shijiazhuang, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old;
  • Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
  • Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
  • Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.

Exclusion criteria

  • Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
  • Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
  • Patients with in-stent occlusion;
  • Patients with unprotected left main coronary artery disease;
  • Women who are pregnant or lactating;
  • Patients who are participating in clinical trials of other drugs or medical devices;
  • Patients with contraindications to the investigational device;
  • Other patients considered by the investigators to be unsuitable for this trial.

Treatment and study plan

microcatheter

Device

supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media

Primary outcomes

  1. Technical success

    Time frame: 0 day

    Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.

Secondary outcomes

  1. Device success

    Time frame: 0 day

    Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.

  2. Procedural success

    Time frame: 0 - 7 days

    Defined as meeting all the following criteria:

    • After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3;
    • No all-cause death, Q-wave myocardial infarction, stroke, cardiac tamponade, target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) before discharge.

  3. Device super-selective angiography (if applicable)

    Time frame: 0 day

    the microcatheter shall deliver the contrast agent to the designated location and develop

  4. Guide wire exchange supported (if applicable)

    Time frame: 0 day

    successful exchange of the guide wire

  5. Device Performance Evaluation

    Time frame: 0 day

    The investigators will evaluate the device performance according to the use and operation of the device during the procedure

Other outcomes

  1. Major adverse cardiac events (MACE) during the study

    Time frame: 0 - 7 days

    Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).

  2. Adverse events and serious adverse events related to the study device during the study

    Time frame: 0 - 7 days

  3. Occurrence of other adverse events and serious adverse events during the study

    Time frame: 0 - 7 days

Sponsors and collaborators

Lead sponsor

BrosMed Medical Co., Ltd

Industry

Registry information

Official study title

A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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