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In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
In-stent Restenosis Lesion
Paclitaxel-eluting balloon catheter, Everolimus-eluting stent
Seoul National University Hospital
Korea, Republic of
Not yet recruiting
Seoul National University Hospital
Published on BioPortfolio: 2014-08-27T03:14:59-0400
The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective ...
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameter...
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month...
The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in nativ...
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Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.
Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.
Use of a balloon catheter to block the flow of blood through an artery or vein.
The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...
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