Clinical Trials Logo

Clinical Trial Summary

The study is a prospective, multinational (Italy and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in small vessels (≤2.5 mm) with respect to Net Gain (mm) at 6 months follow-up


Clinical Trial Description

A prospective, randomized, multi-centre study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.5mm). Vessel size will be determined first by QCA on-line (screening, pre-procedure). If, based on QCA on-line the vessel size pre-procedure is ≤2.5mm and following a successful pre-dilatation (i.e. no angiographic dissections type CDEF and TIMI>2), the subject will be randomized in a 1:1 fashion to Magic Touch or SeQuent Please Neo. OCT will be performed post pre-dilatation (guidance) prior to drug coated balloon (DCB) treatment. The DCB balloon size will be selected based on OCT measurements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03913832
Study type Interventional
Source Concept Medicals BV
Contact
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date December 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Terminated NCT02528474 - Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents N/A
Recruiting NCT03471234 - Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Completed NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Active, not recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT03226262 - FFRangio Accuracy vs. Standard FFR
Recruiting NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Elective Percutaneous Coronary Intervention Phase 4
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03709836 - Computed Tomography Angiography Prediction Score for Side Branch Occlusion
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Not yet recruiting NCT03646019 - Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT03518437 - Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A