Clinical trials: Coronary Stent Restenosis
Coronary Artery Disease
Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR).
- Trial name
- NCT02528474
- Testing
- balloon angioplasty with Pantera Lux, balloon angioplasty with SeQuent Please
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Yonsei University
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 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
Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.
- Trial name
- NCT00936780
- Testing
- Infinnium-Core™ Paclitaxel eluting Coronary Stent
- Where
- 7 sites in India
- Volunteers
- 67 people
- Sponsor
- Sahajanand Medical Technologies Limited
Acute Coronary Syndrome, Angina Pectoris
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different…
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Trial name
- NCT04475380
- Testing
- Percutaneous coronary intervention
- Where
- 2 sites in Netherlands
- Volunteers
- 1,757 people
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
Coronary Heart Disease
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled…
- Trial name
- NCT05552911
- Testing
- Pretreatment strategies before drug balloon therapy, Different types of in-stent restenosis were treated with drug-coated balloons
- Where
- China
- Volunteers
- 400 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Coronary Disease, Coronary Artery Disease
EXecutive Registry: 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 (NCT01310309)
- Testing
- Coronary artery placement of a drug-eluting stent
- Where
- 23 sites in Italy
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
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
Stents, Coronary Artery Disease
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V®…
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis
- Trial name
- NCT00180479
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 1,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Genetics Study of In-stent Restenosis
The investigators hypothesized that genetic variants of G protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).
- Trial name
- ISR (NCT01670396)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Shanghai Zhongshan Hospital
Coronary Disease, Coronary Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- XIENCE V India (NCT00631228)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- 18 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS) and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.
- Trial name
- BASE-ACS (NCT00819923)
- Testing
- Percutaneous coronary intervention
- Where
- 6 sites in Finland
- Volunteers
- 825 people
- Sponsor
- The Hospital District of Satakunta
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.
Coronary Artery Insufficiency
FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.
- Trial name
- NCT00242892
- Testing
- Intra coronary measures of pressure
- Where
- France
- Volunteers
- 800 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Coronary Heart Disease
The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general.
- Trial name
- NCT02219594
- Testing
- CT image for patient with suspected in-stent restenosis
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Xuzhou Central Hospital
Coronary Artery Disease
Impaired Peripheral Endothelial Function and In-stent Restenosis
The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).
- Trial name
- NCT02131935
- Where
- Japan
- Volunteers
- 513 people
- Sponsor
- Kumamoto University
Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD)
Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group…
- Conditions
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD), De Novo Stenosis
- Trial name
- DEBATE (NCT05516446)
- Testing
- DEB for de Novo Lesions, DES for de Novo Lesions
- Where
- Tunisia
- Volunteers
- 290 people
- Sponsor
- General Administration of Military Health, Tunisia
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Cardiovascular Diseases, Coronary Artery Disease
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery…
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- Trial name
- ASSURE ROT (NCT01915420)
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.