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Rotational Atherectomy Prior to Taxus Stent

2014-08-27 03:42:21 | BioPortfolio

Summary

The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.

Description

Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.

Study Design

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

Conditions

Complex Calcified Coronary Lesions

Intervention

Rotational Atherectomy

Location

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH
Bad Segeberg
Germany
23795

Status

Recruiting

Source

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:21-0400

Clinical Trials [1958 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge. Observational studies demonstrate that moderate or severe calcifications in lesions to tr...

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hy...

Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI

The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older ge...

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study

Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into microscopic ...

Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II)

Calcified lesions related to coronary artery are a type of atherosclerosis, accompanied by severe calcified lesions of the stenosis, which is a difficult point for PCI interventional thera...

PubMed Articles [5291 Associated PubMed Articles listed on BioPortfolio]

Rotational Atherectomy in CTO-lesions: too risky? Outcome of Rotational Atherectomy in CTO-lesions Compared to non-CTO-lesions.

To determine the feasibility of Rotational Atherectomy (RA) in chronic total occlusion (CTO)-PCI and compare success- and complication rates of RA in CTO-lesions versus non-occluded lesions. Data on R...

Procedural and long-term ischemic outcomes of tight subtotal occlusions treated with orbital atherectomy: An ORBIT II subanalysis.

Orbital atherectomy is an effective treatment strategy to modify severely calcified coronary lesions prior to stent placement. Traversing a severely calcified subtotal occlusion with the crown may be ...

Feasibility and clinical outcome of rotational atherectomy in patients presenting with an acute coronary syndrome.

We aimed to investigate the feasibility, safety, and outcome of rotational atherectomy (RA) in the setting of acute coronary syndrome (ACS).

Orbital Atherectomy of Severely Calcified Unprotected Left Main Coronary Artery Disease: One-Year Outcomes.

We assessed the 1-year outcomes of patients who underwent orbital atherectomy for severely calcified unprotected left main coronary artery (ULMCA) disease.

Procedural and One-Year Outcomes of Patients Treated with Orbital and Rotational Atherectomy with Mechanistic Insights from Optical Coherence Tomography.

We sought to evaluate procedural complications and 1-year clinical outcomes for patients who underwent percutaneous coronary intervention (PCI) with orbital (OA) and rotational atherectomy (RA).

Medical and Biotech [MESH] Definitions

Percutaneous transluminal procedure for removing atheromatous plaque from the coronary arteries. Both directional (for removing focal atheromas) and rotational (for removing concentric atheromatous plaque) atherectomy devices have been used.

A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.

The formation of dentin. Dentin first appears in the layer between the ameloblasts and odontoblasts and becomes calcified immediately. Formation progresses from the tip of the papilla over its slope to form a calcified cap becoming thicker by the apposition of new layers pulpward. A layer of uncalcified dentin intervenes between the calcified tissue and the odontoblast and its processes. (From Jablonski, Dictionary of Dentistry, 1992)

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

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