NCT05801003

Brief Summary

Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur. Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

3 active sites

Status
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

February 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

March 11, 2023

Last Update Submit

February 28, 2024

Conditions

Coronary Artery DiseasePercutaneous Coronary InterventionCutting Balloon

Outcome Measures

Primary Outcomes (1)

  • Minimum stent area post-stenting measured by optimal coherence tomography (OCT)

    Immediately after the procedure

Secondary Outcomes (14)

  • Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).

    9 month follow-up.

  • Mean stent area measured by optimal coherence tomography

    9 month follow-up.

  • Acute procedural success

    Immediately after the procedure

  • Coronary disection

    Immediately after the procedure

  • Malapposition (Major/minor) post-stenting measured by optimal coherence tomography

    Immediately after the procedure and at 9 month follow-up

  • +9 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Pre-dilation with cutting balloon followed by ASES implantation.

Device: Predilation with cutting balloon.

Control group

ACTIVE COMPARATOR

Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.

Device: Predilation with conventional balloon

Interventions

Predilation with cutting balloon.DEVICE

PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.

Also known as: Wolverine Cutting balloon
Study group
Predilation with conventional balloonDEVICE

PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)

Control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \>50% in a native coronary artery.

You may not qualify if:

  • Cardiogenic shock
  • Patients presenting with ST-segment elevation myocardial infarction
  • Patients undergoing chronic total occlusions PCI
  • Patients undergoing left main PCI
  • Patients undergoing venous bypass graft lesions PCI
  • Patients with in-stent restenosis
  • Inability to provide informed consent
  • Life expectancy \<1year due to non-cardiac disease
  • Currently participating in another trial before reaching first endpoint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Hospital General de Valencia

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multicenter, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Cardiology, MD, PhD

Study Record Dates

First Submitted

March 11, 2023

First Posted

April 6, 2023

Study Start

February 1, 2023

Primary Completion

April 1, 2024

Study Completion

January 1, 2025

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

ES(3)