NCT05998252Completed
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Source: ClinicalTrials.gov · Last updated 10 Jan 2024
Brief summary (registry, in English)
This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 12 Feb 2023
- Start date
- 27 Dec 2022
- Primary completion date
- 29 Aug 2023
- Lead sponsor
- BrosMed Medical Co., Ltd
- Diseases
- Coronary artery disease
- NCT number
- NCT05998252
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 27 Dec 2022 to the primary completion date, 29 Aug 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 with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure;
- Patients who are participating in the clinical trial of other drugs or medical devices;
Other illness
- 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 restenosis;
- Patients who plan to treat 3 or more lesions at the same time;
- Patients with severe calcified lesions;
- Patients in whom the guidewire cannot pass through the lesion;
- Women who are pregnant or lactating;
- Other patients considered by the investigator to be unsuitable for this trial.
Who the study is looking for
- Age ≥ 18 years old, gender is not limited;
- Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI);
- Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;
- Patients or their guardians who can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can accept follow-up;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanxi Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Renmin Hospital of Wuhan University/Hubei General Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Seventh People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.