Comparing drug eluting balloons to stents for treating coronary lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.