Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT06247982
Active, not recruiting Observational

Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions

NCT06247982 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-11-06
Last updated
2025-01-30

Condition(s) studied

DCBDe Novo StenosisPCI

Study summary

The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is:

\- if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI.

Participants will receive DCB PCI in de novo coronary stenosis. Treatments they\'ll be given should be:

* DCB-only PCI
* BOS PCI

Researchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure.

Target vessel is the primary endpoint, defined as:

* cardiovascular death
* target vessel myocardial infarction
* clinical driven target vessel revascularization
* angiographic restenosis

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * De novo DCB PCI of at least one coronary artery * Hybrid PCI of bifurcation (main branch stent and side branch DCB) * Hybrid PCI of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and DCB PCI segment) Exclusion Criteria: * in-stent restenosis * more than 1 year life expectancy

Primary outcome measure(s)

  • Target Vessel Failure of de novo PCI — 1 year
    Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliero-Universitaria di Bologna Bologna Italy

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Radiological Diagnostics in Patients With Deep Endometriosis Recruiting
Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia Recruiting
An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program Recruiting
Phenotypic and Genotypic Characterisation of a Large, Multicentre Italian Cohort of 46, XY DSD Patients Recruiting
Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome Active, not recruiting

Other trials for the same condition

Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial Active, not recruiting
DCB vs. DES in Bifurcation Coronary Lesions Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06247982 on ClinicalTrials.gov ↗ ← All trials in Italy