Comparing drug eluting balloons to stents for treating coronary lesions
TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
PHASE4 · Cardiocentro Ticino · NCT05674630
This study is testing whether a special balloon treatment works better than standard stents for people with long-lasting heart artery blockages.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiocentro Ticino (other) |
| Locations | 1 site (Lugano) |
| Trial ID | NCT05674630 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Magic Touch drug eluting balloon compared to standard drug eluting stent strategies in patients with chronic coronary syndrome and long coronary lesions. Eligible participants will be randomly assigned to receive either treatment after undergoing coronary angiography. The study will assess outcomes based on successful lesion preparation and follow-up at 6 or 12 months. The goal is to determine which approach yields better results in managing coronary lesions.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic coronary syndrome and significant de novo coronary lesions suitable for percutaneous coronary intervention.
Not a fit: Patients with acute coronary syndrome or severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with chronic coronary syndrome.
How similar studies have performed: Other studies have shown promising results with drug eluting balloons, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lugano
- Marco Valgimigli — Lugano, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Marco Valgimigli, M.D., Ph.D — Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
- Study coordinator: Marco Valgimigli, M.D., Ph.D
- Email: marco.valgimigli@eoc.ch
- Phone: +410918115111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Coronary Syndrome, adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES