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OpenTrials
Completed

NCT Number: NCT05750927

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

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

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Key information

Conditions

Aortic Valve Stenosis Angioplasty, Balloon, Coronary Aortic Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Transcatheter Aortic Valve Replacement Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST GOM Niguarda

Milan, 20162, Italy

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • Severe, symptomatic aortic stenosis with an indication to TAVI
  • Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)
  • Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI
  • Three-vessel disease
  • Last remaining vessel
  • Bifurcation PCI (proximal bifurcation)
  • Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)
  • Lesion length > 30 mm
  • Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO

Treatment and study plan

Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)

Procedure

TAVI and PCI to be administered as per physician's indication and choice, in one or more stages

Primary outcomes

  1. POCE

    Time frame: 1 year

    all-cause deaths, strokes (any), myocardial infarction and major bleedings

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Acronym: ASCOP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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