Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Phase 4

Recruiting

• Conditions: Chronic Coronary Syndrome
• Interventions: Device: Magic Touch drug eluting balloon based strategy; Device: Drug-eluting stent-based strategy

• Registration Number: NCT05674630
• Lead Sponsor: Cardiocentro Ticino

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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-06
• Study Start: 2023-02-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08
• Primary Completion: 2026-06-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up	Magic Touch drug eluting balloon based strategy	Patients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.
Drug eluting stent based strategy - 6/12 months invasive follow up	Drug-eluting stent-based strategy	Percutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.

Primary Outcome Measures

Name	Time	Method
Absolute change of FFR values (ΔFFR)	At 6(±30days) or 12(±30 days) months after the index PCI	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

Secondary Outcome Measures

Name	Time	Method
Lumen volume (LV, mm^3)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Lumen volume (LV, mm\^3) evaluated with intravascular ultrasound (IVUS)
Plaque burden (VV-LV)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)
Late lumen loss (LLL)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)
Acute gain	pre procedure and immediately after the procedure	Variation between pre treatment (T0) and immediately after the treatment (Tf)
QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography.
QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography.
Vessel volume (VV, mm^3)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Vessel volume (VV, mm\^3) evaluated with intravascular ultrasound (IVUS)
Target lesion revascularization (TLR) defined as urgent and non-urgent	5 years after the index PCI	Rate of target lesion revascularization (TLR) defined as urgent and non-urgent
Any myocardial infarction	5 years after the index PCI	Rate of any myocardial infarction
QFR parameters before and after intervention and at follow-up angiography	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography
QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography.
QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography.
FFR parameters before and after intervention and at follow-up angiography	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography
Minimal lumen diameter (MLD, mm)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)
Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization	5 years after the index PCI	Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization
The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)	5 years after the index PCI	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)
Definite or probable stent thrombosis	5 years after the index PCI	Rate of definite or probable stent thrombosis
Minimal luminal area (MLA, mm^2)	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) evaluated with intravascular ultrasound (IVUS)
Maximal diameter stenosis (MaxS, percent)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI	Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)
Stroke	5 years after the index PCI	Rate of stroke
Disease progression after index PCI	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the 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)
Target vessel revascularization (TVR), defined as urgent and non-urgent	5 years after the index PCI	Rate of target vessel revascularization (TVR), defined as urgent and non-urgent

Trial Locations

Locations (1)

Marco Valgimigli; 🇨🇭 Lugano, Switzerland