Clinical trials: Vascular Lesion
PAD, Vascular Calcification
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of…
- Trial name
- OPTIMIZE BTK (NCT02561299)
- Testing
- Peripheral Orbital Atherectomy System, 014 Drug Coated Balloon
- Where
- 7 sites in Austria, Germany
- Volunteers
- 66 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
TAXUS PERSEUS Small Vessel
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo…
- Trial name
- PERSEUS SV (NCT00489541)
- Testing
- Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
- Where
- 28 sites in United States
- Volunteers
- 224 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary…
- Trial name
- NCT00231283
- Testing
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
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
Heart Defects, Congenital
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries.
- Trial name
- XEL-CR-06 (NCT02377700)
- Testing
- Xeltis Vascular Patch, Model COR-VP-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
The Jetstream G3™ Calcium Study
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
- Trial name
- NCT01273623
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in United States
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT03847233
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Boston Scientific Corporation
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Atherosclerosis
PE PREMIER CHINA CLINICAL TRIAL
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
- Trial name
- NCT02230254
- Testing
- Percutaneous coronary intervention PROMUS PREMIER
- Volunteers
- 101 people
- Sponsor
- Boston Scientific Corporation
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
Atherosclerosis, Coronary Artery Disease
The OMEGA Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
- Trial name
- NCT01419171
- Testing
- OMEGA™ Monorail Coronary Stent System
- Where
- 37 sites in United States, Belgium and 5 more
- Volunteers
- 328 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel…
- Trial name
- RI-US XL (NCT01913600)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Medtronic Vascular
Arterial Occlusive Diseases, Myocardial Ischemia
RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the…
- Conditions
- Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- RJ-SVS (NCT01150500)
- Testing
- MDT-4107 Zotarolimus-Eluting Coronary Stent
- Where
- Japan
- Volunteers
- 65 people
- Sponsor
- Medtronic Vascular
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 Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices