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Recruiting NCT05674630

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Phase IV Interventional Chronic Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magic Touch drug eluting balloon based strategy, Drug-eluting stent-based strategy.
Who it may be relevant to
Registry conditions: Chronic Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Absolute change of FFR values (ΔFFR) [Time frame: At 6(±30days) or 12(±30 days) months after the index PCI]
Secondary outcome measures (12)
  • QCA parameter (minimal lumen diameter, MLD, mm) before and 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 [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 [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. [Time frame: 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 [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 [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) [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) [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) [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) [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) [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) [Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Marco Valgimigli — Lugano

Identifiers

NCT: NCT05674630 · 01_TITAN-DEB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗