Clinical trials: Coronary Stent Restenosis
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
Restenosis, Stable Angina Pectoris
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)
- Conditions
- Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
- Trial name
- ISAR-DESIRE 4 (NCT01632371)
- Testing
- Paclitaxel Eluting Balloon + Scoring Balloon, Paclitaxel Eluting Balloon
- Where
- 2 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease
Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France
The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years…
- Trial name
- Far XIENCE V® (NCT00987506)
- Testing
- XIENCE V®
- Where
- 58 sites in France
- Volunteers
- 1,165 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Treatment of In-Stent Restenosis 2 Study
The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents…
- Trial name
- TIS2 (NCT03667313)
- Testing
- sirolimus-eluting balloon (SEB) MagicTouch, paclitaxel-eluting balloon (PEB) Sequent Please
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- University Hospital Ostrava
Coronary Occlusion, Coronary Stenosis
STAR and Deferred Stenting Study
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a…
- Conditions
- Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
- Trial name
- STAR (NCT05089864)
- Testing
- Stent Placement Timing - Early, Stent Placement Timing - Late
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Saint Luke's Health System
Coronary Arterial Disease (CAD), In Stent Restenosis
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
- Conditions
- Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions
- Trial name
- OPEN-SAFE (NCT07646444)
- Testing
- non compliant balloon
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Minneapolis Heart Institute Foundation
Coronary Artery Disease, Coronary Restenosis
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant…
- Trial name
- NCT00426049
- Testing
- Everolimus
- Where
- Germany
- Volunteers
- 484 people
- Sponsor
- German Heart Institute
Coronary In-stent Restenosis
Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis
Over the past two decades, stents implantation has developed as a standard treatment for coronary stenosis lesions. However, int-stent restenosis (ISR) was one of the main factors affecting the long-term efficacy of coronary…
- Trial name
- NCT04213378
- Testing
- Paclitaxel eluting PTCA balloon, SeQuent® Please paclitaxel eluting balloon
- Where
- China
- Volunteers
- 212 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Artery Disease
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent…
- Trial name
- NCT04405063
- Testing
- Paclitaxel Coated PTCA Balloon Catheter
- Volunteers
- 82 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease
V-Flex Plus PTX Drug Eluting Coronary Stent
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
- Trial name
- ELUTES III (NCT00225693)
- Testing
- drug eluting coronary stent
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Cook Group Incorporated
In-stent Coronary Artery Restenosis
Prognostic Assessment of Different Pattern of Bifurcation Restenosis
The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.
- Trial name
- LATINA (NCT01411475)
- Testing
- Bifurcation restenosis classification
- Where
- 2 sites in Italy
- Sponsor
- Ospedale Santa Maria Goretti
In-stent Restenosis, Major Adverse Cardiovascular Events
Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)
The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients…
- Trial name
- NCT05623995
- Testing
- PCSK9 inhibitor, Statin
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Lin Zhao
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
In Stent Restenosis
Focal In-stent Restenosis After Drug-Eluting Stent
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
- Trial name
- FOCUS (NCT00485004)
- Testing
- Cutting balloon, Sirolimus-eluting stent
- Where
- 15 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease, Coronary Artery Stenosis
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02229864
- Testing
- Coronary artery stenting: Absorb BVS
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Lesion
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
The primary objectives of this trial are: In patients at high-risk for restenosis, To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in…
- Trial name
- Compare Absorb (NCT02486068)
- Testing
- ABSORB scaffold, Xience
- Where
- 44 sites in Belgium, Czechia and 7 more
- Volunteers
- 1,670 people
- Sponsor
- European Cardiovascular Research Center
Coronary Restenosis
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
- Trial name
- NCT03242096
- Testing
- Sirolimus coated balloon, Paclitaxel coated balloon
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 50 people
- Sponsor
- InnoRa GmbH
Coronary Instent Restenosis
A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent
The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon…
- Trial name
- PEPCAD (NCT01622075)
- Testing
- SeQuent® Please, Taxus Liberte
- Where
- China
- Volunteers
- 220 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Coronary Heart Disease, Diabetes
OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents.
- Conditions
- Coronary Heart Disease, Diabetes, Vascular Lesions, Chronic Total Occlusion of Coronary Artery
- Trial name
- OPERA (NCT01861860)
- Testing
- TAXUS™ Element long stent
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Coronary Artery Disease
The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.
- Trial name
- NCT01368627
- Testing
- Supralimus® Sirolimus-Eluting Coronary Stent
- Where
- 7 sites in Brazil
- Volunteers
- 1,274 people
- Sponsor
- Sahajanand Medical Technologies Limited