Advertisement

Topics

Optimal Predilatation Technique for BVS Implantation

2016-10-28 05:53:22 | BioPortfolio

Summary

The purpose of this study is to determine the optimal way of predilatation for BVS implantation.

Description

Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Stenosis

Intervention

Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex), Predilatation with cutting balloon (Flextome)

Status

Not yet recruiting

Source

Cardiology Center Agel

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-28T05:53:22-0400

Clinical Trials [687 Associated Clinical Trials listed on BioPortfolio]

TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested tha...

Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold). Hypothesis: Predilatation with non-c...

The preDIlatation in tRanscathEter aortiC Valve implanTation Trial

This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure...

DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis

The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%)...

Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

The main objective of the Indian SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloo...

PubMed Articles [830 Associated PubMed Articles listed on BioPortfolio]

Automated Balloon Control in Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA).

The goal of this work was to demonstrate technical feasibility of automated balloon pressure management during REBOA in the pre-clinical setting.

The influence of the nylon balloon stiffness on the efficiency of the intra-aortic balloon occlusion.

In interventional procedures the balloon inflation is used to occlude the artery and thus reduce bleeding. There is no practically accepted measure of the procedure efficiency. A finite element method...

Focus on the Perimeter and Skip the Balloon: Can Atrial Septal Defect Be Percutaneously Closed Without Balloon Sizing in the Era of 3-Dimensional Echocardiography?

Clinical utility of novel ultrathin single-balloon enteroscopy: a feasibility study.

 The advent of balloon-assisted enteroscopy (BAE) has facilitated the examination of the entire digestive tract. However, using a rigid sliding tube during the procedure reduces patient acceptance. ...

Bioresorbable vascular scaffold implantation for severely calcified lesions after excimer laser lesion preparation.

Bioresorbable vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, CA) temporarily elute antiproliferative drugs and provide vessel support, which then subsequently resorb to allow restoratio...

Medical and Biotech [MESH] Definitions

The use of balloon CATHETERS to remove emboli by retraction of the balloon that is inflated behind the EMBOLUS.

A balloon-assisted enteroscopy utilizing a flexible endoscope with one overtube balloon control unit.

Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.

Counterpulsation in which a pumping unit synchronized with the patient's electrocardiogram rapidly fills a balloon in the aorta with helium or carbon dioxide in early diastole and evacuates the balloon at the onset of systole. As the balloon inflates, it raises aortic diastolic pressure, and as it deflates, it lowers aortic systolic pressure. The result is a decrease in left ventricular work and increased myocardial and peripheral perfusion.

Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.

More From BioPortfolio on "Optimal Predilatation Technique for BVS Implantation"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Abbott
The 11th largest pharmaceutical company in the world, <!--LGfEGNT2Lhm-->Abbott Laboratories generated sales of $16 billion in 2009 and has 90,000 employees. Within the <!--LGfEGNT2Lhm-->medical device arm of the company, products of note ar...

Stent
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. &...

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...


Searches Linking to this Trial