NCT06247982

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 31, 2024

Last Update Submit

January 29, 2025

Conditions

DCBDe Novo StenosisPCI

Keywords

DCBPCIde novoBail-out stentingTVF

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Failure of de novo PCI

    Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)

    1 year

Study Arms (2)

DCB de novo PCI

All patients who received a de novo DCB PCI

BOS PCI

All patients who received a stent after DCB treatment of de novo coronary lesion because of high grade dissection or recoil more than 30%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All de novo DCB PCI ≥ 18 years-old patients who meet inclusion/exclusion criteria.

You may qualify if:

  • 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)

You may not qualify if:

  • in-stent restenosis
  • more than 1 year life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Study Officials

  • Gabriele Ghetti, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

November 6, 2023

Primary Completion

January 28, 2025

Study Completion

January 28, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)