Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321757
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-02-16
Brief Title:
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Sponsor:
Fundación EPIC
Organization:
Fundación EPIC
Study Overview
Official Title:
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PARIS
Brief Summary:
Post-market prospective observational multicenter non-intervention study to demonstrate the effectiveness of drug-coated ballon DCBtherapy in real-world patients with small native vessel coronary artery disease and to demonstrate the safety of short dual antiplatelet therapy 7 days in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy A percutaneous coronary intervention PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician
Detailed Description:
Post-market prospective multicenter non-intervention study to demonstrate the effectiveness of drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease and to demonstrate the safety of short dual antiplatelet therapy 7 days in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy A PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician The angiographic study will be analyzed in a core lab icicorelab blinded to the procedural outcomes and the patients follow-up
As per clinical practice 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days a second assessment at 6 months and one final assessment at 12 months
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score 25- patients will be included in a high-bleeding risk substudy The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team
As per clinical practice 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days a second assessment at 6 months and one final assessment at 12 months
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score 25- patients will be included in a high-bleeding risk substudy The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team
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?:
None
Is an FDA AA801 Violation?:
None