Clinical trials: In-stent Restenosis
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
In-stent Restenosis
Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.
- Trial name
- GENISPIRE (NCT05656118)
- Testing
- Genoss® DCB
- Where
- 10 sites in South Korea
- Volunteers
- 260 people
- Sponsor
- Yonsei University
Coronary Restenosis
Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)
The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
- Trial name
- NCT00409981
- Testing
- paclitaxel coated balloon catheter (device with drug)
- Where
- 5 sites in Germany
- Volunteers
- 56 people
- Sponsor
- University Hospital, Saarland
CHD - Coronary Heart Disease, Percutaneous Coronary Intervention
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
- Conditions
- CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis
- Trial name
- NCT03809754
- Testing
- Percutaneous Coronary Intervention under OCT, Percutaneous Coronary Intervention under Angiography
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Chinese PLA General Hospital
Coronary Disease, Coronary Artery Disease
EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease
The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis
- Trial name
- EXecutive (NCT00531011)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent System, TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
- Where
- 24 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES
Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the…
- Trial name
- ISAR-DESIRE 3A (NCT02367495)
- Testing
- PCB
- Where
- Germany
- Volunteers
- 125 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease
Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR
The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).
- Trial name
- NCT04767022
- Testing
- Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Genoss Co., Ltd.
Patients Above 18 Years
Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial below-the knee interventions.
- Trial name
- NCT00163254
- Testing
- abciximab, stent and drug eluting stent
- Where
- Germany
- Sponsor
- University Hospital Tuebingen
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 Heart Disease, Percutaneous Coronary Intervention
The Relationship Between Anxiety, Depression and Stent Restenosis After Percutaneous Coronary Intervention
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, the incidence of ISR is as high as 10%-20% at 3-6 months after PCI.
- Trial name
- NCT04811976
- Where
- China
- Volunteers
- 400 people
- Sponsor
- The First Hospital of Qinhuangdao
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.
Coronary Artery Disease, In-Stent Restenosis
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.
- Trial name
- REFORM (NCT04079192)
- Testing
- Biolimus A9 Drug Coated Balloon, SeQuent Please Paclitaxel Drug Coated Balloon
- Where
- 15 sites in Germany, Ireland and 3 more
- Volunteers
- 201 people
- Sponsor
- Biosensors Europe SA
Femoropopliteal In-stent Restenosis
JetStream Atherectomy for the Treatment of In-stent Restenosis
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic…
- Trial name
- JET-ISR (NCT02730234)
- Testing
- JetStream XC with balloon angioplasty
- Where
- 13 sites in United States
- Volunteers
- 60 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Coronary Artery Disease, Stent Restenosis
Matrix Metalloproteinases Expression in the Neointimal Hyperplasia Induced by Drug Eluting Stent (DES) Implantation
If intimal growth is such that the initial lumen is narrowed significantly, distal blood flow is restricted and chronic tissue ischemia results.
- Trial name
- NCT03375528
- Testing
- DES implantation
- Volunteers
- 50 people
- Sponsor
- Dankook University
Percutaneous Coronary Intervention, Optical Coherence Tomography
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
- Conditions
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- Trial name
- SOLEMN (NCT03474432)
- Testing
- Optical Coherence Tomography
- Where
- 13 sites in United States
- Volunteers
- 12 people
- Sponsor
- Jesse Brown VA Medical Center
Stable Angina
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation
This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs.
- Trial name
- REVER (NCT03214900)
- Volunteers
- 20 people
- Sponsor
- Hospital San Carlos, Madrid
Vessel Restenosis
Dexamethasone-Eluting Stent in Acute Coronary Syndrome to Prevent Restenosis
The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathophysiological response of the vascular tissue to the balloon injury.
- Trial name
- NCT00190099
- Testing
- Dexamethasone-Eluting Stent
- Volunteers
- 40 people
- Sponsor
- Far Eastern Memorial Hospital
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 Arterial Disease (CAD)
The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent…
- Trial name
- NCT07159087
- Testing
- Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Genoss Co., Ltd.
In-stent Restenosis
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter
Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.
- Trial name
- NCT02891018
- Testing
- paclitaxel controlled release balloon catheter Vasoguard TM, paclitaxel release coronary balloon catheter SeQuent Please
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd