Status Approved
First Submitted Date
2021/03/30
Registered Date
2021/04/08
Last Updated Date
2021/04/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006072 |
---|---|
Unique Protocol ID | CNUH-2021-046 |
Public/Brief Title | Feasibility of percutaneous coronary intervention via left snuffbox approach in patients with coronary bifurcation lesions |
Scientific Title | Feasibility of percutaneous coronary intervention via left snuffbox approach in patients with coronary bifurcation lesions |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | CNUH-2021-046 |
Approval Date | 2021-02-22 |
Institutional Review Board Name | Chonnam national university hospital institutional review board |
Institutional Review Board Address | 42, Jebong-ro, Dong-gu, Gwangju |
Institutional Review Board Telephone | 062-220-5257 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Myung Ho Jung |
Title | Pf. |
Telephone | +82-31-5189-8967 |
Affiliation | Chonnam National University Hospital |
Address | 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea |
Contact Person for Public Queries | |
Name | Oh-Hyun Lee |
Title | Pf |
Telephone | +82-31-5189-8786 |
Affiliation | Yonsei University Yongin Severance Hospital |
Address | 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea |
Contact Person for Updating Information | |
Name | Oh-Hyun Lee |
Title | Pf. |
Telephone | +82-31-5189-8786 |
Affiliation | Yonsei University Yongin Severance Hospital |
Address | 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-03-02 Actual | |
Target Number of Participant | 106 | |
Primary Completion Date | 2021-03-30 , Actual | |
Study Completion Date | 2022-03-01 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-03-02 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Yonsei University Yongin Severance Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Transradial approach (TRA) is widely accepted and recommended as the standard approach for coronary angiography and any percutaneous coronary intervention (PCI) irrespective of clinical presentation. Trans-radial cardiac catheterization has been reported to be more beneficial compared to femoral approaches with easier hemostasis, better patient comfort, earlier ambulation, shorter hospital stay and less occurrence of short-term cardiac death, myocardial infarction and access-site complications. However, the use of TRA is not free of limitations, as the radial artery is prone to spasm and often presents anatomical variation including severe tortuosity or loop formation, which can lead to obligatory crossover to other arterial access. Although previous studies have shown significantly lower rates of subclavian tortuosity and slightly shorter fluoroscopy times with left radial access compared to the right., left radial access is used less often, as it is not as ergonomic for the operator, especially for prolonged or complex PCI and in obese patients. Kiemeneji has recently proposed the radial artery cannulation in the anatomical snuffbox as an alternative radial artery cannulation. This new approach can overcome some drawbacks of standard radial artery approach in several aspects. Since the first publication in May 2017, several studies reported the safety and feasibility of the distal radial approach (DRA). Coronary bifurcation lesions are involved in 15-20% of all PCI and remain one of the most complex and challenging lesions in terms of procedural success rate as well as long-term cardiac event. (9) However, there is a paucity of data regarding the feasibility of the DRA for the bifurcation PCI. This study sought to investigate the efficacy and safety of the distal radial approach in PCI for bifurcation lesion. |
---|
8. Study Design
Study Type | Observational Study |
---|---|
Observational Study Model | Case-only |
Time Perspective | Retrospective |
Target Number of Participant | 106 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients underwent bifurcation PCI via left distal radial artery |
Cohort/Group Description We performed a single center, retrospective cohort study of patients who underwent PCI for bifurcation lesions via left DRA. From the medical records of 1,041 consecutive patients with Snuffbox approach in Chonnam National University Hospital (Dec 2017 to Dec 2019), we identified 446 patients with successfully treated the coronary artery disease. Among them, we enrolled 106 patients who were treated with bifurcation PCI via left DRA We will evaluate the success rate of PCI, cross-over rate of the puncture site for pci, access-site complications including major bleeding requiring surgery or transfusion, hematoma, distal and forearm radial artery occlusion, and 30-day mortality. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | 1,041 consecutive patients in the Snuffbox registry of Chonnam National University Hospital (Dec 2017 to Dec 2019) |
---|---|
Sampling Method | We performed a single center, retrospective cohort study of patients who underwent PCI for bifurcation lesions via left DRA. From the medical records of 1,041 consecutive patients in the Snuffbox database of Chonnam National University Hospital (Dec 2017 to Dec 2019), we identified 446 patients with successfully treated the coronary artery disease. Among them, we enrolled 106 patients who were treated with bifurcation PCI via left DRA. |
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I25.1)Atherosclerotic heart disease Coronary artery disease patients who underwent PCI for bifurcation lesions via left DRA |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description patients in the Snuffbox registry of Chonnam National University Hospital (Dec 2017 to Dec 2019) |
|
Exclusion Criteria |
no specific exclusion criteria |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Success rate of percutaneous coronary intervention |
|
Timepoint | just after procedure |
|
Secondary Outcome(s) 1 | ||
Outcome | Cross over rate of puncture site |
|
Timepoint | just after procedure |
|
Secondary Outcome(s) 2 | ||
Outcome | 30day mortality |
|
Timepoint | one month after index procedure |
|
Secondary Outcome(s) 3 | ||
Outcome | radial artery occlusion |
|
Timepoint | one month after index procedure |
|
Secondary Outcome(s) 4 | ||
Outcome | major bleeding requiring admission or surgery |
|
Timepoint | one month after index procedure |
|
Secondary Outcome(s) 5 | ||
Outcome | access-site complication |
|
Timepoint | one month after index procedure |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동