Back to resultsEvaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Alveo HP Balloon Dilatation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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 known to be intolerant to antiplatelet drugs or allergic to contrast media; Patients with in-stent restenosis; Patients with unprotected left main coronary artery disease; 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; Patients who are participating in the clinical trial of other drugs or medical devices; Other patients considered by the investigator to be unsuitable for this trial.
Sites / Locations
- The Seventh People's Hospital of ZhengzhouRecruiting
- Renmin Hospital of Wuhan University Hubei General Hospital
- Shanxi Cardiovascular Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alveo balloon dilatation catheter
Arm Description
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter.
Outcomes
Primary Outcome Measures
Procedural Success Rate
Defined as meeting all the following criteria:
After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3;
No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up.
Secondary Outcome Measures
Device Success Rate
Defined as meeting all the following criteria:
Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter;
No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation.
Device Performance Evaluation
The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance.
Full Information
NCT ID
NCT05998252
First Posted
February 12, 2023
Last Updated
August 16, 2023
Sponsor
BrosMed Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05998252
Brief Title
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Official Title
A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrosMed Medical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alveo balloon dilatation catheter
Arm Type
Experimental
Arm Description
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter.
Intervention Type
Device
Intervention Name(s)
Alveo HP Balloon Dilatation Catheter
Intervention Description
Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.
Primary Outcome Measure Information:
Title
Procedural Success Rate
Description
Defined as meeting all the following criteria:
After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3;
No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Device Success Rate
Description
Defined as meeting all the following criteria:
Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter;
No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation.
Time Frame
0 day
Title
Device Performance Evaluation
Description
The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance.
Time Frame
0 day
Other Pre-specified Outcome Measures:
Title
Incidence of major adverse cardiac events (MACE) during the study.
Description
Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).
Time Frame
0 - 7 days
Title
Adverse events and serious adverse events rate
Description
Adverse events and serious adverse events related to the study device during the study.
Time Frame
0 - 7 days
Title
Other Adverse events and serious adverse events rate
Description
Occurrence of other adverse events and serious adverse events
Time Frame
0 - 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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 known to be intolerant to antiplatelet drugs or allergic to contrast media;
Patients with in-stent restenosis;
Patients with unprotected left main coronary artery disease;
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;
Patients who are participating in the clinical trial of other drugs or medical devices;
Other patients considered by the investigator to be unsuitable for this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niu Siquan
Phone
(0371)61207777
Email
siquanniu@sohu.com
Facility Information:
Facility Name
The Seventh People's Hospital of Zhengzhou
City
Zhenzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niu Siquan
Phone
(0371)61207777
Email
siquanniu@sohu.com
Facility Name
Renmin Hospital of Wuhan University Hubei General Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jingping
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Bo
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
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