Health TrialsbyHealthPanel

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

ConditionChronic Coronary Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiocentro Ticino

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow upExperimental treatment 1 intervention
Group B: Drug eluting stent based strategy - 6/12 months invasive follow upActive comparator 1 intervention

Trial outcomes

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

Time frame
At 6(±30days) or 12(±30 days) months after the index PCI

Secondary outcomes

1

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.

Time frame
pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
2

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.

Time frame
pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
3

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.

Time frame
pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
4

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.

Time frame
pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardiocentro Ticino

Lead sponsor

University of Bern

Collaborator

Source ClinicalTrials.gov
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