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In-Stent Restenosis clinical trials

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NCT ID: NCT05512832 Completed - In-stent Restenosis Clinical Trials

In-stent Restenosis and Pericoronary Fat Attenuation Index

Start date: January 1, 2020
Phase:
Study type: Observational

This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.

NCT ID: NCT05509296 Completed - Coronary Stenosis Clinical Trials

Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

NCT ID: NCT05112250 Completed - Clinical trials for Coronary Artery Calcification

IVL for Stent Underexpantsion

IVL-DRAGON
Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).

NCT ID: NCT04985773 Completed - Coronary Stenosis Clinical Trials

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

EXPANSE-PTCA
Start date: December 17, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

NCT ID: NCT04415216 Completed - In Stent Restenosis Clinical Trials

DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)

DEB-DRAGON
Start date: October 10, 2019
Phase:
Study type: Observational [Patient Registry]

Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.

NCT ID: NCT04268875 Completed - In-stent Restenosis Clinical Trials

Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

RESTO
Start date: December 11, 2019
Phase: N/A
Study type: Interventional

The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome (ACS). The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred. In symptomatic stent restenosis (angina or acute coronary syndrome), a further angioplasty is usually required, occasionally on an emergency basis. Coronary angiography is often not capable of explaining the mechanical causes of this complication. Optical coherence tomography (OCT), a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment. OCT during angiography provides a detailed analysis of the stents and potential complications: the presence of neoatherosclerosis with or without plaque rupture, intimal hyperplasia, stent under-deployment, stent fracture and distal or proximal progression of the atherosclerosis. The investigators propose a prospective, multicentre study of all cases of intrastent restenosis, examined by angiography, causing clinical features involving stable angina and acute coronary syndrome. The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis. The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment. There are several possible treatments for restenosis, including balloon angioplasty, coated balloon angioplasty, stenting or aorto-coronary bypass graft surgery.

NCT ID: NCT04240444 Completed - Clinical trials for Coronary Artery Disease

Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis

SIBLINT ISR
Start date: October 10, 2020
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.

NCT ID: NCT03260517 Completed - Clinical trials for Coronary Artery Disease

The PREVAIL Study

PREVAIL
Start date: October 2, 2017
Phase: N/A
Study type: Interventional

To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

NCT ID: NCT00916279 Completed - In-Stent Restenosis Clinical Trials

PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

PERVIDEO I
Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.

NCT ID: NCT00485030 Completed - In-stent Restenosis Clinical Trials

Diffuse Type In-Stent Restenosis After Drug-Eluting Stent

DES-ISR
Start date: March 2007
Phase: Phase 4
Study type: Interventional

To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.