NCT05782738

Brief Summary

The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. Nowadays, no studies compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Trial Health

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Trial Health Score

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

Enrollment
361

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
37mo left

Started Jun 2023

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Jun 2023Jun 2029

First Submitted

Initial submission to the registry

March 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

March 11, 2023

Last Update Submit

April 14, 2023

Conditions

Coronary Artery DiseaseCoronary StenosisCoronary Disease

Keywords

Reverse TAPExternal MinicrushCoronary bifurcation lesion

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF) (Composite of all causes of death, non-fatal TVMI, ischemia-driven target lesion revascularisation (TLR) + Definite or probable ST+ ISR >50% at planned coronary angiography or Coro-TC.

    The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).

    12-moths

Secondary Outcomes (2)

  • Cardiac death + TVMI + ST

    5-years

  • Cardiac death + TVMI + ST +TLR

    5-years

Other Outcomes (12)

  • Acute closure of the side branch and periprocedural-MI.

    Periprocedural

  • Intraprocedural ST and periprocedural-MI

    Periprocedural

  • Major bleeding (BARC 3 and 5)

    5-years

  • +9 more other outcomes

Study Arms (2)

Reverse TAP

ACTIVE COMPARATOR
Procedure: Percutaneous Coronary Intervention

External Minicrush

ACTIVE COMPARATOR
Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE

Use dedicated two stents technique for treatment of coronary bifurcation stenosis

External MinicrushReverse TAP

Eligibility Criteria

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

You may qualify if:

  • Patients \>18 years old;
  • Patients with an indication of PCI, including Chronic Coronary syndrome (CCS) and Acute Coronary Syndrome (ACS), according to current guidelines recommendations; According to Medina and Definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation.

You may not qualify if:

  • Patients that refused informed consent;
  • Patients without valid vascular access that could make unsafe PCI;
  • Patients with an expected life of less than one year;
  • Patients with scheduled major surgery that required prolonged DAPT interruption;
  • Pregnant patients;
  • Patients with DAPT contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ciriè Hospital

Cirié, Tori O, 10073, Italy

Location

Ospedale Santa Croce

Moncalieri, Torino, 10024, Italy

Location

Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

L'Azienda Ospedaliera (AO) S. Croce e Carle

Cuneo, 12100, Italy

Location

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy

Turin, 10100, Italy

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary StenosisCoronary Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Giulio Piedimonte, MD

    Ospedale degli Infermi di Rivoli (TO)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Piedimonte, MD

CONTACT

+393201764900giulio.piedimonte@gmail.com

Enrico Cerrato, MD, phD

CONTACT

enrico.cerrato@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiology

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 24, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2029

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(5)