Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons (TITAN-DEB)

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndrome
• Intervention / Treatment: Device: Magic Touch drug eluting balloon based strategy; Device: Drug-eluting stent-based strategy

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marco Valgimigli, M.D., Ph.D; Phone Number: +410918115111; Email: marco.valgimigli@eoc.ch
• Study Contact Backup: Name: Enrico Frigoli, M.D.; Email: enrico.frigoli@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Marco Valgimigli
    • Contact: Enrico Frigoli, MD; Phone Number: +410918115111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up; 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.	Device: Magic Touch drug eluting balloon based strategy; 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.
Active Comparator: Drug eluting stent based strategy - 6/12 months invasive follow up; 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.	Device: Drug-eluting stent-based strategy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 6(±30days) or 12(±30 days) months after the index PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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	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	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)	5 years after the index PCI
Any myocardial infarction	Rate of any myocardial infarction	5 years after the index PCI
Stroke	Rate of stroke	5 years after the index PCI
Definite or probable stent thrombosis	Rate of definite or probable stent thrombosis	5 years after the index PCI

Collaborators and Investigators

• Sponsor: Cardiocentro Ticino
• Collaborators: University of Bern
• Investigators: Principal Investigator: Marco Valgimigli, M.D., Ph.D, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: adult; drug eluting stent; drug eluting balloon; percutaneous intervention; chronic coronary syndrome; significant de novo coronary lesion; FFR≤0.80; iFR≤0.89; long DES (≥30 mm); coronary lesion; Magic Touch drug eluting balloon
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 01_TITAN-DEB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No