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

NCT05750927 | Completed

• 1 other identifier: 723-1412202
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• POCE

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

  1 year

Study Arms (1)

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)

Interventions

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

ASCoP (severe Aortic Stenosis with Complex PCI features)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

Location

Related Publications (1)

• Montalto C, Munafo AR, Soriano F, Arslani K, Brunner S, Verhemel S, Cozzi O, Mangieri A, Buono A, Squillace M, Nava S, Diez Gil JL, Scotti A, Foroni M, Esposito G, Mandurino-Mirizzi A, Bauer D, Ornelas B, Codner P, Piayda K, Porto I, Marco F, Sievert H, Kornowski R, Tousek P, Fischetti D, Latib A, Sanchez JS, Maffeo D, Bedogni F, Reimers B, Regazzoli D, Mieghem NV, Sondergaard L, Saia F, Toggweiler S, Backer O, Oreglia JA. Outcomes of complex, high-risk percutaneous coronary intervention in patients with severe aortic stenosis: the ASCoP registry. EuroIntervention. 2025 Apr 21;21(8):e426-e436. doi: 10.4244/EIJ-D-24-00933.

  PMID: 40259842 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Interventions

Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Endovascular Procedures; Vascular Surgical Procedures; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

IT (1)