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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanxi Cardiovascular Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Renmin Hospital of Wuhan University/Hubei General Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The Seventh People's Hospital of Zhengzhou
Coordinator of this site? Confirm its status
ZhenzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.