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NCT05750927 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— ASCOP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05750927
Other study ID # 723-1412202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date December 31, 2023

Study information
Verified date March 2024
Source Niguarda Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 1. Severe, symptomatic aortic stenosis with an indication to TAVI 2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features) 1. Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI 2. Three-vessel disease 3. Last remaining vessel 4. Bifurcation PCI (proximal bifurcation) 5. Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon) 6. Lesion length > 30 mm 7. Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
TAVI and PCI to be administered as per physician's indication and choice, in one or more stages

Locations
Country Name City State
Italy ASST GOM Niguarda Milano

Sponsors (1)
Lead Sponsor Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary POCE all-cause deaths, strokes (any), myocardial infarction and major bleedings 1 year
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