Magic Touch drug eluting balloon based strategyDrug-eluting stent-based strategy
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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Absolute change of FFR values (ΔFFR) — At 6(±30days) or 12(±30 days) months after the index PCI 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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