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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

NCT05778773

Aortic Valve Stenosis

RECRUITING

Act on Quality of Life in Patients With aortIc Stenosis

NCT06477042

Severe Aortic Stenosis

RECRUITING

Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.

NCT05708118

Bicuspid Aortic Valve Aortic Valve Stenosis Aortic Aneurysm +4 more

UNKNOWN

Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

NCT05326126

Severe Symptomatic Aortic Stenosis

COMPLETED NA

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

NCT06589063

Low Flow, Low Gradient Aortic Stenosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Angioplasty, Balloon, Coronary Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASCoP (severe Aortic Stenosis with Complex PCI features)

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

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

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No