Clinical trials: In-Stent Restenosis
de Novo or Restenosis Lesions
MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: A mounted Cobalt Chromium (CoCr) alloy based stent A Rapid Exchange (RX) Coronary System Delivery System A Poly…
- Trial name
- JNIR (NCT02828917)
- Testing
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
- Where
- Japan
- Volunteers
- 104 people
- Sponsor
- Medinol Ltd.
DES In-stent Stenosis
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent…
- Trial name
- FIMLIMUSDCB (NCT02996318)
- Testing
- Paclitaxel coated balloon (SeQuent Please), Sirolimus coated balloon
- Where
- 5 sites in Malaysia
- Volunteers
- 50 people
- Sponsor
- InnoRa GmbH
Coronary Artery Disease, Coronary Restenosis
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs.
- Trial name
- AbsorbISR (NCT02474485)
- Testing
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography.
- Where
- Switzerland
- Volunteers
- 53 people
- Sponsor
- SIS Medical AG
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN Sub-study
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01182428
- Testing
- XIENCE V®/ XIENCE PRIME™, CYPHER SELECT
- Where
- 25 sites in Argentina, Austria and 13 more
- Volunteers
- 455 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in…
- Trial name
- NCT02944890
- Testing
- Drug Eluting Balloon Catheters(RESTORE DEB）, Drug Eluting Balloon Catheters(SeQuent® Please）
- Where
- 14 sites in China
- Volunteers
- 242 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
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
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Angina Pectoris, Coronary Artery Disease
A Safety Study of ABI-007 for In-Stent Restenosis
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries.
- Trial name
- NCT00093223
- Testing
- Paclitaxel Nanoparticle Albumin Bound
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Celgene
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
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 Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis
This study consisted of a randomized controlled trial group and a long balloon observation group. In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the…
- Trial name
- NCT04733443
- Testing
- Biolimus, SeQuent® Please Neo
- Where
- China
- Volunteers
- 310 people
- Sponsor
- JW Medical Systems 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.
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Coronary Disease
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™…
- Trial name
- NCT00165035
- Testing
- CoStar Paclitaxel Drug Eluting Coronary Stent System, TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
- Where
- 2 sites in United States
- Volunteers
- 1,701 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for…
- Trial name
- ENDEAVOR III (NCT00217256)
- Testing
- Percutaneous Coronary Stenting
- Volunteers
- 436 people
- Sponsor
- Medtronic Vascular
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation