Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSan Luigi Gonzaga Hospital

About this trial

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >18 years of age

Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)

Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1

Disqualifiers

Patients who do not want or cannot sign the informed consent for the procedure.

Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.

Patients with a life expectancy of <1 year.

Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.

Trial population

ACS or CCS patients with complex coronary bifurcation lesions with the indication of PCI.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Coronary Intervention

    Procedure/Surgery

    Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation. The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.

Treatment groups

382 Participants
are divided into 2 treatment groups
Group A: T-stenting And Minimal Protrusion1 intervention
Group B: External Minicrush1 intervention

Trial outcomes

Primary outcomes

1

Target Lesion Failure (TLF)

a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

Time frame
5-years

Secondary outcomes

1

Stent thrombosis (ST)

Thrombosis of the stent after PCI

Time frame
5-years
2

Intrastent-restenosis (ISR)

Intrastent restenosis with \>50% of the stent diameter

Time frame
5-years
3

Target Vessel MI (TVMI)

Target vessel myocardial infarction at follow-up

Time frame
5-years

Other outcomes

Sponsors and contacts

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