Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Phase 4RecruitingNCT05674630

Cardiocentro Ticino130 enrolled

Overview

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Chronic Coronary Syndrome

Interventions

Magic Touch drug eluting balloon based strategyDEVICE

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Drug-eluting stent-based strategyDEVICE

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI 2. At least one significant de-novo coronary lesion (defined as diameter stenosis \> 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings 3. Written informed consent Exclusion Criteria: 1. Patients referred to the index procedure for an acute coronary syndrome 2. Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery 3. Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment 4. Spontaneous coronary artery dissection (SCAD) 5. Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate \<50 beats/min and systolic blood pressure \<90 mmHg) 6. Known pregnancy or breast-feeding patients 7. Life expectancy \<1 year due to other severe non-cardiac disease 8. Legally incompetent to provide informed consent 9. Participation in another clinical study with an investigational product

Locations (1)

Marco Valgimigli

Lugano, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Absolute change of FFR values (ΔFFR)

Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months

Time frame: At 6(±30days) or 12(±30 days) months after the index PCI

Secondary Outcomes

QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography

Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography

Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography.

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography

Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.

Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Central Contacts

Marco Valgimigli, M.D., Ph.D

CONTACT

+410918115111 marco.valgimigli@eoc.ch

Enrico Frigoli, M.D.

CONTACT

enrico.frigoli@eoc.ch

Data from ClinicalTrials.gov

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QFR parameters before and after intervention and at follow-up angiography

Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

FFR parameters before and after intervention and at follow-up angiography

Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Minimal lumen diameter (MLD, mm)

Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Minimal luminal area (MLA, mm^2)

Minimal luminal area (MLA, mm\^2) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Maximal diameter stenosis (MaxS, percent)

Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Lumen volume (LV, mm^3)

Lumen volume (LV, mm\^3) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Vessel volume (VV, mm^3)

Vessel volume (VV, mm\^3) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Plaque burden (VV-LV)

Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Late lumen loss (LLL)

Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Acute gain

Variation between pre treatment (T0) and immediately after the treatment (Tf)

Time frame: pre procedure and immediately after the procedure

Disease progression after index PCI

Variation between final result of index PCI (Tf) and procedure at 6(±30days) or 12(±30 days) months after the index PCI (Tc)

Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Target lesion revascularization (TLR) defined as urgent and non-urgent

Rate of target lesion revascularization (TLR) defined as urgent and non-urgent

Time frame: 5 years after the index PCI

Target vessel revascularization (TVR), defined as urgent and non-urgent

Rate of target vessel revascularization (TVR), defined as urgent and non-urgent

Time frame: 5 years after the index PCI

Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

Time frame: 5 years after the index PCI

The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Time frame: 5 years after the index PCI

Any myocardial infarction

Rate of any myocardial infarction

Time frame: 5 years after the index PCI

Stroke

Rate of stroke

Time frame: 5 years after the index PCI

Definite or probable stent thrombosis

Rate of definite or probable stent thrombosis

Time frame: 5 years after the index PCI