Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

NCT05674630 | Recruiting Phase 4

• 1 other identifier: 01_TITAN-DEB
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up

EXPERIMENTAL

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

Drug eluting stent based strategy - 6/12 months invasive follow up

ACTIVE COMPARATOR

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

Interventions

Magic Touch drug eluting balloon based strategy DEVICE

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.

Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up

Drug-eluting stent-based strategy DEVICE

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.

Drug eluting stent based strategy - 6/12 months invasive follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
• 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
• Written informed consent

You may not qualify if:

• Patients referred to the index procedure for an acute coronary syndrome
• Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
• Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment
• Spontaneous coronary artery dissection (SCAD)
• 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)
• Known pregnancy or breast-feeding patients
• Life expectancy \<1 year due to other severe non-cardiac disease
• Legally incompetent to provide informed consent
• Participation in another clinical study with an investigational product

Sponsors & Collaborators

• Cardiocentro Ticino: lead
• University of Bern: collaborator

Study Sites (1)

Marco Valgimigli

Lugano, 6900, Switzerland

RECRUITING

Study Officials

• Marco Valgimigli, M.D., Ph.D

  Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Valgimigli, M.D., Ph.D

CONTACT

+410918115111; marco.valgimigli@eoc.ch

Enrico Frigoli, M.D.

CONTACT

enrico.frigoli@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 6, 2023
• Study Start: February 21, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CH (1)