NCT05674630 Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
| NCT ID | NCT05674630 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cardiocentro Ticino |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-02-21 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2023-02-21 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marco Valgimigli, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
Frequently Asked Questions
Who can join the NCT05674630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05674630 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05674630 currently recruiting?
Yes, NCT05674630 is actively recruiting participants. Contact the research team at marco.valgimigli@eoc.ch for enrollment information.
Where is the NCT05674630 trial being conducted?
This trial is being conducted at Lugano, Switzerland.
Who is sponsoring the NCT05674630 clinical trial?
NCT05674630 is sponsored by Cardiocentro Ticino. The principal investigator is Marco Valgimigli, M.D., Ph.D at Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,. The trial plans to enroll 130 participants.