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Restenosis clinical trials

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NCT ID: NCT01405248 Completed - Restenosis Clinical Trials

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

BPRIAS
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether butylphthalide are effective for Preventing Restenosis after Intracranial and Extracranial Artery Stenting

NCT ID: NCT01298947 Enrolling by invitation - Restenosis Clinical Trials

Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions

PHOTOPAC
Start date: April 2011
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation

NCT ID: NCT01267838 Completed - Clinical trials for Coronary Artery Disease

Culotte Technique Versus TAP Stunting for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents

BBK2
Start date: February 2010
Phase: Phase 4
Study type: Interventional

BBK- 2 - study: STUDY-SUMMARY Background: The need for stenting of the main and side branch (double stenting) in the treatment of coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion. If the bifurcation lesion is very complex (Medina classification 111, severe stenosis of both branches, severe calcified lesion, long lesions etc.) double stenting may be the treatment of choice. When double stenting is required, the most frequently used stenting techniques are T-stenting and Culotte-stenting. It is still unclear, however, which double stent technique yields the best long-term outcome. Aim: This randomized study will compare the long-term safety and efficacy of T-stenting versus Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting stents. Methods: Three-hundred patients in whom a double-stenting technique is intended for the treatment of a de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is the maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary endpoints include binary restenosis (estimated by Quantitative Coronary Angiography (QCA) analysis), Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events (MACE) and the rate of stent thrombosis according to the definition of the Academic Research Consortium (ARC definition). The study will have 90% power to detect a 25% reduction in the primary endpoint at p < 0.05.

NCT ID: NCT01257438 Active, not recruiting - Restenosis Clinical Trials

FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

RESCUE
Start date: December 2010
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the AV access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.

NCT ID: NCT01065532 Completed - Restenosis Clinical Trials

SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study

SEDUCE
Start date: May 2009
Phase: N/A
Study type: Interventional

Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study. A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.

NCT ID: NCT01016509 Completed - Restenosis Clinical Trials

Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis

Start date: December 2009
Phase: N/A
Study type: Interventional

A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the investigators will assess whether the tight glycemic control during the first month from coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.

NCT ID: NCT00987324 Completed - Heart Disease Clinical Trials

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

ISAR-DESIRE-3
Start date: July 2009
Phase: Phase 4
Study type: Interventional

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 in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

NCT ID: NCT00798954 Completed - Clinical trials for Ischemic Heart Disease

Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

SINGLEKISS
Start date: June 2007
Phase: Phase 4
Study type: Interventional

The use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified. Particularly, for bifurcation lesions where stenting the main branch could result in an obstruction of a vital side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and 11-40% for side branch. In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However, the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled operators. For the treatment of relatively distal bifurcation lesions, where first POBA is performed, then the lesion is stented, followed by kissing balloon technique to fully expand the side branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August 2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side branches, suggesting that using two stents may not be necessarily the ideal treatment. The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen access for side-branch treatment. As such, we developed this study to compare the outcomes of paclitaxel-eluting and sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the kissing ballooning technique.

NCT ID: NCT00780156 Terminated - Restenosis Clinical Trials

The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel

ITALIC
Start date: November 2008
Phase: N/A
Study type: Observational

Background Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need for repeat revascularization procedures in patients who undergo PCI. The potential increased incidence of late stent thrombosis prompted cardiologists to prolong the use of dual anti-platelet therapy after the one year duration recommended by the recent ESC guidelines. However, while the premise that the cardiologists should put all their patients on dual clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because of the potential increase of bleeding complications and of the healthcare cost increase. The recent possibility to monitor aspirin with bedside assays offers a real opportunity to compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen versus mono-aspirin regimen and to respond to the key question: can the investigators switch from dual to single antiplatelet therapy after six months in good aspirin responder patients ? Study National, multicenter, randomised prospective open group comparison of dual clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients treated with DES (name: XIENCE) implantation. End point Primary: At 12 months: death, myocardial infarction, repeat urgent revascularization, stroke requiring a new hospitalisation and major bleedings. Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation, of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding complications Participating centres: 60 french centers Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45 months

NCT ID: NCT00774917 Recruiting - Restenosis Clinical Trials

Numen Stent Assessment Using OCT Technique in a Single Center Study

NAUTIC
Start date: October 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI). A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months. It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.