Actively Recruiting
TicIn Study Comparing Magic Touch Drug Eluting Balloon and Drug Eluting Stents for Treatment of Long Coronary Lesions in Chronic Coronary Syndrome
Led by Cardiocentro Ticino · Updated on 2023-09-08
130
Participants Needed
1
Research Sites
405 weeks
Total Duration
On this page
Sponsors
C
Cardiocentro Ticino
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates treatment options for adults with chronic coronary syndrome who have long coronary artery blockages. The study compares a drug eluting balloon called Magic Touch against the standard drug eluting stent approach. Participants are randomly assigned to receive one of these treatments to assess how well they work in managing their coronary lesions. Patients suitable for percutaneous coronary intervention (PCI) will first have their artery lesions prepared to meet specific criteria, including less than 30% residual narrowing and good blood flow without severe artery damage. Then, they will be randomly divided into two groups: one receiving the Magic Touch drug eluting balloon and the other receiving a drug eluting stent. Each group will be further randomized to undergo follow-up invasive assessments either 6 months or 12 months after treatment. During the study, participants will be closely monitored using invasive techniques such as fractional flow reserve (FFR) and intravascular ultrasound (IVUS) to evaluate the arteries at follow-up. The main outcome measured is the change in FFR values at 6 or 12 months after the procedure. This follow-up helps researchers understand the effectiveness of each treatment in improving coronary artery function and guides future management of long coronary lesions.
CONDITIONS
Official Title
Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years old) with chronic coronary syndrome suitable for PCI
- At least one significant de-novo coronary lesion with >50% narrowing and flow-limiting features confirmed by FFR ≤0.80 or iFR ≤0.89
- Lesion intended for treatment with a long (≥30 mm) drug eluting stent based on IVUS findings
- Written informed consent provided
You will not qualify if you...
- Patients treated for an acute coronary syndrome at the index procedure
- Lesions involving the left main coronary artery or ostial segments of left circumflex or right coronary arteries
- Severe kidney impairment (eGFR <15 ml/min/1.73 m²) or currently on dialysis
- Spontaneous coronary artery dissection (SCAD)
- Contraindications to adenosine such as moderate to severe asthma, chronic obstructive pulmonary disease, heart rate <50 bpm, or systolic blood pressure <90 mmHg
- Known pregnancy or breastfeeding
- Life expectancy less than 1 year due to other severe non-cardiac illnesses
- Unable to legally provide informed consent
- Participation in another clinical study involving an investigational product
AI-Screening
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Trial Site Locations
Total: 1 location
1
Marco Valgimigli
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
M
Marco Valgimigli, M.D., Ph.D
E
Enrico Frigoli, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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