Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080919
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2022-09-22
Brief Title:
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention PLAMI
Sponsor:
Hospital Universitario La Fe
Organization:
Hospital Universitario La Fe
Study Overview
Official Title:
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAMI
Brief Summary:
Coronary artery disease CAD is one of the most common causes of mortality worldwide Despite drug eluting stents DES are the most common treatment strategy drug-coated balloons DCB represent an appealing alternative to DES as they eliminate the risk of stent thrombosis and do not leave any type of metallic structure in the vessel wall However the evidence of the vessel wall healing processes plaque remodeling plaque composition and impact on coronary microcirculation after PCI with DCB have not yet been characterized
The purpose of this study is to assess the changes in percentage atheroma volume evaluated by intravascular ultrasound IVUS in patients undergoing DCB-PCI
The purpose of this study is to assess the changes in percentage atheroma volume evaluated by intravascular ultrasound IVUS in patients undergoing DCB-PCI
Detailed Description:
The study will be an investigator-initiated single-arm open-label pilot study in patients undergoing PCI with DCB for the novo lesion
Because of the exploratory nature of this study no formal sample size calculation is required On the basis of previous pilot studies with similar designs a sample of 30 lesions is planned to be evaluated
After being informed about the study and the potential risks all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent Patients will go DCB-PCI IVUS will be evaluated prior to PCI-DCB immediately after and at 3-month follow-up Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software Pulse Medical Imaging Technology Shanghai China The angiography images will be used to obtain the IMRangio values prior post to DCB-PCI and 3 month follow-up
Because of the exploratory nature of this study no formal sample size calculation is required On the basis of previous pilot studies with similar designs a sample of 30 lesions is planned to be evaluated
After being informed about the study and the potential risks all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent Patients will go DCB-PCI IVUS will be evaluated prior to PCI-DCB immediately after and at 3-month follow-up Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software Pulse Medical Imaging Technology Shanghai China The angiography images will be used to obtain the IMRangio values prior post to DCB-PCI and 3 month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None