Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes

Completed

• Conditions: Transcatheter Aortic Valve Replacement; Angioplasty, Balloon, Coronary; Aortic Valve Stenosis; Coronary Artery Disease
• Interventions: Procedure: Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)

• Registration Number: NCT05750927
• Lead Sponsor: Niguarda Hospital

Brief Summary

To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI

Detailed Description

The aims of this study are:

* to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI

* to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes

* to investigate predictors of better outcomes

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASCoP (severe Aortic Stenosis with Complex PCI features)	Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)	Subjects with severe aortic stenosis undergoing transcatheter aortic valve intervention and with concomitant, complex coronary artery disease with a clinical indication for percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
POCE	1 year	all-cause deaths, strokes (any), myocardial infarction and major bleedings

Trial Locations

Locations (1)

ASST GOM Niguarda; 🇮🇹 Milano, Italy