Clinical trials: Restenosis
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length…
- Trial name
- AGENT IDE (NCT06492174)
- Testing
- AGENT DCB 40 mm
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
In-stent Restenosis
Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)
To demonstrate acceptable short term safety rates of the Drug-eluting Coronary Spur Stent System as a primary treatment for coronary in-stent restenosis.
- Trial name
- NCT06117150
- Testing
- Drug-eluting Coronary Spur Stent System
- Where
- 2 sites in New Zealand
- Volunteers
- 9 people
- Sponsor
- ReFlow Medical, Inc.
In-stent Restenosis
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
- Trial name
- NCT05731700
- Testing
- Drug Eluting Balloon
- Where
- 9 sites in France, Georgia and 2 more
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Coronary Stenosis, Coronary Artery Stenosis
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
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.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- NCT05509296
- Testing
- SINOMED CBC, NSE Coronary Dilatation Catheter
- Where
- 8 sites in China
- Volunteers
- 136 people
- Sponsor
- Sino Medical Sciences Technology Inc.
In-Stent Restenosis or De Novo Coronary Artery Lesions
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system.
- Trial name
- NCT07415902
- Testing
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Where
- China
- Volunteers
- 252 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Intracranial Arterial Diseases, Stent Restenosis
The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
- Conditions
- Intracranial Arterial Diseases, Stent Restenosis, Percutaneous Transluminal Angioplasty
- Trial name
- NCT05217459
- Testing
- Self-expanding intracranial drug stent system
- Where
- 14 sites in China
- Volunteers
- 128 people
- Sponsor
- Sinomed Neurovita Technology Inc.
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.
In-Stent Restenosis, Cardiovascular Diseases
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
- Conditions
- In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- MAGICAL ISR (NCT05908331)
- Testing
- Sirolimus Drug Coated Balloon, Plan balloon Angioplasty (POBA)
- Where
- 28 sites in United States
- Volunteers
- 492 people
- Sponsor
- Concept Medical Inc.
Coronary In-stent Restenosis
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery…
- Trial name
- NCT03373695
- Testing
- Dissolve™, SeQuent®Please
- Where
- 15 sites in China
- Volunteers
- 260 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
BIOFLOW-china Post-marketing Study (BIOTRONIK)
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
- Trial name
- BIOFLOW-China (NCT05667285)
- Testing
- BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 122 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Stenosis, Occlusion
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SPORTS (NCT03332264)
- Testing
- SeQuent Please OTW, Eluvia Vascular Stent System, Nitinol stent
- Where
- 10 sites in Austria, Germany
- Volunteers
- 224 people
- Sponsor
- InnoRa GmbH
de Novo, Symptomatic Ischemic Heart Disease
BIOFLOW-SV All Comers Registry
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm.
- Conditions
- de Novo, Symptomatic Ischemic Heart Disease, Restenoses, Coronary
- Trial name
- BIOFLOW-SV (NCT03600948)
- Testing
- Orsiro Sirolimus Eluting Coronary Stent System
- Where
- 2 sites in Brazil
- Volunteers
- 261 people
- Sponsor
- Biotronik AG
Dialysis; Complications, Central Vein Obstruction
APERTO CVS PMCF Study
Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients
- Conditions
- Dialysis; Complications, Central Vein Obstruction, Stenosis, Restenosis
- Trial name
- APERTO CVS (NCT04514406)
- Testing
- APERTO OTW DCB
- Where
- 2 sites in Germany
- Volunteers
- 6 people
- Sponsor
- Cardionovum GmbH
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
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.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
Chronic Total Occlusion of Coronary Artery, Vascular Disease
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-AV DAPT (NCT01106534)
- Testing
- clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
- Where
- 144 sites in United States
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, In Stent Restenosis
Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
- Trial name
- SIBLINT ISR (NCT04240444)
- Testing
- drug-coated balloon Catheter
- Where
- 16 sites in China
- Volunteers
- 260 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.