NCT05856344Completed
A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
A Study for Crossability of Novel Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation：A Multicenter, Randomized, Controlled, Single Blind Trial
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
The goal of this clinical trial is to compare the crossability of novel spherical tip versus regular noncompliant balloon in CHD population with tortuous coronary artery leisions that requiring postdilation after stent implantation. The main question it aims to answer is: •Wether the spherical tip balloon have advantages in terms of crossability compared to regular noncompliant balloons Participants will sign an informed consent form, collaborate with data collection, and accept the intervention measures from corresponding groups. Researchers will compare spherical tip balloon with regular noncompliant balloon to see if there is any difference in crossability.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 250 (actual)
- First submitted
- 4 May 2023
- Start date
- 20 Feb 2023
- Primary completion date
- 27 Aug 2024
- Lead sponsor
- First Hospital of China Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT05856344
What you commit to
- Study type: Interventional
- Participants enrolled: 250
- From 20 Feb 2023 to the primary completion date, 27 Aug 2024
- 1 site 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 participating in clinical trials of other drugs or medical devices
Other
- Pregnant women or patients who are attempting to get pregnant
- Patients deemed unsuitable by the researchers to participate in this clinical trial
Who the study is looking for
- Over 18 years old, regardless of gender
- Patients with indications for coronary artery stent implantation
- The vascular curvature angle\<120 ° after coronary artery stent implantation
- Noncompliant balloon postdilation is required
- Voluntarily participate and sign an informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.