Clinical trial NCT05674630: Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
Official title: TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Coronary Syndrome
Keywords: adult
chronic coronary syndrome
percutaneous intervention
significant de novo coronary lesion
FFR≤0.80
iFR≤0.89
long DES (≥30 mm)
coronary lesion
drug eluting balloon
drug eluting stent
Magic Touch drug eluting balloon
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2023-01-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute change of FFR values (ΔFFR)
timeFrame: At 6(±30days) or 12(±30 days) months after the index PCI
Secondary outcomes:
measure: QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: QFR parameters before and after intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: FFR parameters before and after intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Minimal lumen diameter (MLD, mm)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Minimal luminal area (MLA, mm^2)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Maximal diameter stenosis (MaxS, percent)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Lumen volume (LV, mm^3)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Vessel volume (VV, mm^3)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Plaque burden (VV-LV)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Late lumen loss (LLL)
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Acute gain
timeFrame: pre procedure and immediately after the procedure
measure: Disease progression after index PCI
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
measure: Target lesion revascularization (TLR) defined as urgent and non-urgent
timeFrame: 5 years after the index PCI
measure: Target vessel revascularization (TVR), defined as urgent and non-urgent
timeFrame: 5 years after the index PCI
measure: Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization
timeFrame: 5 years after the index PCI
measure: The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)
timeFrame: 5 years after the index PCI
measure: Any myocardial infarction
timeFrame: 5 years after the index PCI
measure: Stroke
timeFrame: 5 years after the index PCI
measure: Definite or probable stent thrombosis
timeFrame: 5 years after the index PCI
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Marco Valgimigli
Study officials:
affiliation: Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
name: Marco Valgimigli, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: