Clinical trials: Restenoses, Coronary
Coronary Restenosis
Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic…
- Trial name
- ELEGANT (NCT02300454)
- Testing
- Non-slip element balloon (NSE), Balloon
- Where
- 2 sites in Japan
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Mitsui Memorial Hospital
In-stent Coronary Artery Restenosis
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES).
- Trial name
- NCT01835301
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medstar Health Research Institute
Metal Allergy, Contact Allergy
Metal Allergy In-Stent Restenosis Study
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation.
- Conditions
- Metal Allergy, Contact Allergy, Restenoses, Coronary, In-stent Restenosis
- Trial name
- RESTALL (NCT03588962)
- Testing
- In-stent restenosis
- Volunteers
- 1,000 people
- Sponsor
- Silesian Centre for Heart Diseases
Coronary Artery Disease, Coronary Restenosis
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of…
- Conditions
- Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Trial name
- AGENT-ISR (NCT02151812)
- Testing
- Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
- Where
- 12 sites in France, Germany
- Volunteers
- 123 people
- Sponsor
- Hemoteq AG
Coronary Artery Disease, Angina Pectoris
The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente
The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Coronary Stenosis
- Trial name
- TWENTE (NCT01066650)
- Testing
- Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent), Xience V (Everolimus-eluting stent)
- Where
- Netherlands
- Volunteers
- 1,391 people
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Myocardial Ischemia, Coronary Artery Stenosis
SPIRIT PRIME Clinical Trial
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due…
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- SPIRIT PRIME (NCT00916370)
- Testing
- Core size Xience Prime, Xience Prime Long Lesion (LL)
- Where
- 62 sites in United States, Australia
- Volunteers
- 525 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Thrombosis
Scripps Evaluation of Antiplatelet Therapies for Intermediate Duration With the Endeavor Stent (Seaside)
Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual…
- Trial name
- SEASIDE (NCT00963781)
- Testing
- Medtronic Endeavor Stent, Reduced duration (6 months) DAPT
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- Scripps Health
Acute Coronary Syndrome, Angina Pectoris
Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity.
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Trial name
- BIO-RESORT (NCT01674803)
- Testing
- Orsiro, Synergy, Resolute Integrity
- Where
- Netherlands
- Volunteers
- 3,514 people
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
Coronary Restenosis
Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)
Objectives: PRIMARY OBJECTIVE: To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
- Trial name
- NCT00752362
- Testing
- Milennium Matrix® (Control), Infinnium®, Supralimus®
- Where
- 11 sites in Brazil
- Volunteers
- 280 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Restenosis
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following…
- Trial name
- SNAPIST-III (NCT00124943)
- Testing
- Nanoparticle Paclitaxel
- Volunteers
- 112 people
- Sponsor
- Celgene Corporation
Coronary Heart Disease, Coronary Restenosis
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of…
- Trial name
- ORAR III (NCT00552669)
- Testing
- Oral sirolimus, Drug Eluting stent
- Where
- 3 sites in Argentina
- Volunteers
- 200 people
- Sponsor
- Centro de estudios en Cardiologia Intervencionista
Coronary Disease, Coronary Artery Disease
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ZoMaxx™ II (NCT00140101)
- Testing
- ZoMaxx™ Drug-Eluting Coronary Stent System, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 92 sites in United States, Australia and 2 more
- Volunteers
- 1,099 people
- Sponsor
- Abbott Medical Devices
Coronary Disease, Coronary Stenosis
Limus Eluted From A Durable Versus ERodable Stent Coating
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.
- Trial name
- LEADERS (NCT00389220)
- Testing
- Coronary stent placement
- Where
- 10 sites in Belgium, France and 5 more
- Volunteers
- 1,707 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease, Angina Pectoris
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Acute Coronary Syndrome
- Trial name
- BIONYX (NCT02508714)
- Testing
- Orsiro, Resolute Onyx
- Where
- 7 sites in Belgium, Israel and 1 more
- Volunteers
- 2,470 people
- Sponsor
- Thorax Centrum Twente
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis, Coronary Stent Occlusion
Restenosis in Coronary Stents And Cutaneous HEaLing
Case control study of patients with and without restenosis to demonstrate the link between in-stent restenosis and an excessive skin healing.
- Conditions
- Coronary Restenosis, Coronary Stent Occlusion, Skin Scarring, Keloid
- Trial name
- RACHEL (NCT04915391)
- Testing
- Skin biopsy and blood sample for inflammation markers, RNA and proteins
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Drug Eluting Stent
Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals
The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.
- Trial name
- AIFSIDDES (NCT00973375)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Liuhuaqiao Hospital
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.