Clinical trials: Restenoses, Coronary
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 Restenosis
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is…
- Trial name
- BIOLUX-RCT (NCT01651390)
- Testing
- Percutaneous coronary intervention
- Where
- 14 sites in Germany, Latvia
- Volunteers
- 231 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.
- Trial name
- NCT01308346
- Testing
- Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Chronic Coronary Occlusion
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort…
- Conditions
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- XV CHINA SAS (NCT01249027)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,605 people
- Sponsor
- Abbott Medical Devices
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
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
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
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB B (NCT00856856)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 12 sites in Australia, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
In-stent Coronary Artery Restenosis
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.
- Trial name
- DEBREST (NCT01485068)
- Testing
- Danubio paclitaxel-eluting balloon
- Where
- 8 sites in France
- Volunteers
- 44 people
- Sponsor
- MINVASYS
Coronary Disease, Coronary Artery Disease
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- NCT01171820
- Testing
- TAXUS® Liberté™, XIENCE V® EECSS
- Where
- 28 sites in Austria, France and 9 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
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
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 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 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 Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Coronary Occlusion, Thrombosis (Stent Thrombosis)
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System…
- Conditions
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia
- Trial name
- NCT01178268
- Testing
- XIENCE V EECSS, CYPHER SELECT PLUS SECSS
- Where
- 2 sites in China
- Volunteers
- 546 people
- Sponsor
- Abbott Medical Devices
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
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices
Coronary Disease, Coronary Artery Disease
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT V (NCT00402272)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- 93 sites in Austria, Belgium and 21 more
- Volunteers
- 2,700 people
- Sponsor
- Abbott Medical Devices
Chronic Coronary Occlusion, Vascular Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval 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 Coronary Occlusion, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-LTF (NCT01120379)
- Testing
- XIENCE V® EECSS
- Where
- United States
- Volunteers
- 5,034 people
- Sponsor
- Abbott Medical Devices