NCT05747287Completed
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Source: ClinicalTrials.gov · Last updated 19 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 17 Feb 2023
- Start date
- 17 Jan 2023
- Primary completion date
- 3 Oct 2023
- Lead sponsor
- BrosMed Medical Co., Ltd
- Diseases
- Coronary artery disease
- NCT number
- NCT05747287
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 17 Jan 2023 to the primary completion date, 3 Oct 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are participating in clinical trials of other drugs or medical devices;
- Patients with contraindications to the investigational device;
Other illness
- 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 unprotected left main coronary artery disease;
Other
- Patients with in-stent occlusion;
- Women who are pregnant or lactating;
- Other patients considered by the investigators to be unsuitable for this trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The Seventh People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.