Clinical trials: Coronary Stenting
Angina, Chronic Coronary Occlusion
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the…
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- NCT01086228
- Testing
- XIENCE V / PROMUS stent
- Where
- 47 sites in Japan
- Volunteers
- 2,010 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Ischemia
Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent
The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- MEND II (NCT02189499)
- Testing
- AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 4 sites in Colombia
- Volunteers
- 42 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Israel Satellite Registry
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01895712
- Where
- 6 sites in Israel
- Volunteers
- 120 people
- Sponsor
- BIOTRONIK Israel
Angina Pectoris
A Prospective, Single-arm, Multi-centre, Observational, Real World Registry
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
- Trial name
- Morpheus (NCT02901353)
- Testing
- Sirolimus Eluting Coronary Stent System
- Where
- 5 sites in Hungary, Jordan and 2 more
- Volunteers
- 400 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Stable Coronary Disease, Unstable Coronary Disease
Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen
To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin +…
- Conditions
- Stable Coronary Disease, Unstable Coronary Disease, Documented Silent Ischemia
- Trial name
- BEST (NCT01122719)
- Testing
- Drug Eluting Stent
- Where
- 2 sites in Brazil, Italy
- Volunteers
- 16 people
- Sponsor
- CID - Carbostent & Implantable Devices
Coronary Artery Disease, High Bleeding Risk Patients
ULTRA LONG: BioFreedom Ultra
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk…
- Trial name
- NCT05643430
- Testing
- BioFreedom Ultra
- Where
- 9 sites in France, United Kingdom
- Volunteers
- 86 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease
A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
1. Prospective, randomized, multicenter clinical study 2. This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways.
- Trial name
- NCT03716011
- Testing
- EXCROSSAL
- Where
- China
- Volunteers
- 2,700 people
- Sponsor
- JW Medical Systems Ltd
Coronary Artery Disease
Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in…
- Trial name
- NCT03429894
- Testing
- Percutaneous Coronary Intervention
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 50 people
- Sponsor
- Elixir Medical Corporation
Coronary Stenosis, Coronary Artery Disease
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
This is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system
- Trial name
- NCT06071702
- Testing
- IoNIR Ridaforolimus-Eluting Coronary Stent System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
Coronary Artery Disease
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) >36 mm and ≤ 44 mm in length (by…
- Trial name
- BIOFLOW-48 (NCT06779630)
- Testing
- Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
- Where
- 23 sites in United States, Austria and 4 more
- Volunteers
- 150 people
- Sponsor
- Teleflex
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Coronary Restenosis
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in…
- Trial name
- NCT02944890
- Testing
- Drug Eluting Balloon Catheters(RESTORE DEB）, Drug Eluting Balloon Catheters(SeQuent® Please）
- Where
- 14 sites in China
- Volunteers
- 242 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Coronary Artery Disease
Acrobat Coronary Stent System Effectiveness European Study
The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any…
- Trial name
- ACES (NCT01761591)
- Testing
- PCI with Svelte Acrobat, PCI with other BMS
- Where
- 12 sites in Belgium, France and 1 more
- Volunteers
- 300 people
- Sponsor
- Svelte Medical Systems Europe
Coronary Artery Disease (CAD)
BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)
The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB…
- Trial name
- BASKET BALL (NCT07363161)
- Testing
- PCI
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 2,184 people
- Sponsor
- B. Braun Melsungen AG
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Myocardial Ischemia, Coronary Artery Stenosis
Safety Study of a Bioresorbable Coronary Stent
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- RESTORE (NCT01262703)
- Testing
- ReZolve Stent
- Where
- Brazil
- Volunteers
- 49 people
- Sponsor
- REVA Medical, Inc.
Coronary Artery Disease
Study of the Orsiro Drug Eluting Stent System
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo…
- Trial name
- BIOFLOW-II (NCT01356888)
- Testing
- Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES), Percutaneous Coronary Intervention (Orsiro DES)
- Where
- 24 sites in Austria, France and 6 more
- Volunteers
- 452 people
- Sponsor
- Biotronik AG
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
Device Related MACE and Bleeding
e-BioMatrix Canada Registry
Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology centers. The e-BioMatrix data will be compared with a historical control group, the Cypher arm of the Biosensors Leaders study consisting…
- Trial name
- NCT01915628
- Testing
- BioMatrix Flex
- Where
- 4 sites in Canada
- Volunteers
- 535 people
- Sponsor
- Biosensors Europe SA