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

• Sponsor: Niguarda Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05750927
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 4.9
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Angioplasty, Balloon, Coronary; Coronary Artery Disease	Procedure: Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	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

Outcome Measures

Primary Outcome Measures

1. POCE [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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)

3. Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI

4. Three-vessel disease

5. Last remaining vessel

6. Bifurcation PCI (proximal bifurcation)

7. Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)

8. Lesion length > 30 mm

9. Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST GOM Niguarda	Milano		Italy	20162

Sponsors and Collaborators

• Niguarda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Niguarda Hospital
• ClinicalTrials.gov Identifier: NCT05750927
• Other Study ID Numbers: 723-1412202
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Aortic Valve Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Mar 2, 2023