Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

NCT ID: NCT05674630

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2030-12-01

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.

Conditions

Chronic Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Magic Touch drug eluting balloon based strategy

Intervention Type: 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 - 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.

Group Type: ACTIVE_COMPARATOR

Drug-eluting stent-based strategy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Cardiocentro Ticino

OTHER

Sponsor Role: lead

Responsible Party

Marco Valgimigli

Coordinating Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Valgimigli, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

Locations

Marco Valgimigli

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Marco Valgimigli, M.D., Ph.D

Role: CONTACT

marco.valgimigli@eoc.ch

+410918115111

Enrico Frigoli, M.D.

Role: CONTACT

enrico.frigoli@eoc.ch

Facility Contacts

Enrico Frigoli, MD

Role: primary

+410918115111

Other Identifiers

01_TITAN-DEB

Identifier Type: -

Identifier Source: org_study_id