Clinical trials: Stent Restenosis
Coronary Angioplasty, Restenosis
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis.
- Conditions
- Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent
- Trial name
- OSCAR (NCT07316504)
- Testing
- Intravascular lithotripsy, Balloon
- Where
- 2 sites in France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Clermont-Ferrand
Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans
Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life.
- Conditions
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular, In-stent Restenosis
- Trial name
- CIVILIAN (NCT05473884)
- Testing
- lesion preparation devices, conventional balloon
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Shanghai Pudong Hospital
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
In-Stent Restenosis
Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in native coronary arteries with reference…
- Trial name
- NCT00998439
- Testing
- SeQuent® Please, SeQuent® II
- Where
- 8 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Klinikum Coburg
Instent Restenosis
The Valentines Trial
The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up.
- Trial name
- NCT01066832
- Testing
- Paclitaxel
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 276 people
- Sponsor
- Eurocor GmbH
Coronary Artery Disease
Valsartan for Suppression of Plaque Volume and Restenosis After Drug-Eluting Stent
To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.
- Trial name
- VAL-SUPPRES (NCT00589732)
- Testing
- Valsartan
- Where
- 5 sites in South Korea
- Volunteers
- 220 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease, Diabetes Mellitus
Second-generation Drug-eluting Stents in Diabetes
This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting…
- Trial name
- SUGAR (NCT03321032)
- Testing
- Polymer-free amphilimus-eluting stents, Biolinx Polymer-based zotarolimus-eluting stents
- Where
- 23 sites in Spain
- Volunteers
- 1,164 people
- Sponsor
- Spanish Society of Cardiology
Coronary Occlusion, Coronary Stenosis
STAR and Deferred Stenting Study
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a…
- Conditions
- Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
- Trial name
- STAR (NCT05089864)
- Testing
- Stent Placement Timing - Early, Stent Placement Timing - Late
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Saint Luke's Health System
Chronic Mesenteric Ischemia, Stent Stenosis
Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.
Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms.
- Trial name
- ESTIMEC (NCT03586739)
- Testing
- endovascular angioplasty using covered stents, endovascular angioplasty using bare metal stents, Duplex-scan
- Where
- 20 sites in France
- Volunteers
- 179 people
- Sponsor
- Hospices Civils de Lyon
Coronary Artery Disease
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients…
- Trial name
- NCT00192868
- Testing
- Distal protection and drug eluting stent
- Where
- Denmark
- Volunteers
- 600 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
In-stent Coronary Artery Restenosis
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
- Trial name
- PEPPER (NCT00961181)
- Testing
- Paclitaxel Releasing Balloon
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Biotronik AG
Coronary Stent Restenosis
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).
- Trial name
- OPEN-ISR (NCT04862052)
- Testing
- Intravascular management of prior implanted coronary drug eluting stent restenosis
- Where
- 2 sites in Hungary
- Volunteers
- 108 people
- Sponsor
- Semmelweis University Heart and Vascular Center
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Coronary Artery Disease
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary…
- Trial name
- NCT00192881
- Testing
- Bx Sonic & Cypher stent from Cordis
- Where
- Denmark
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
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, In Stent Restenosis
Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
- Trial name
- SIBLINT ISR (NCT04240444)
- Testing
- drug-coated balloon Catheter
- Where
- 16 sites in China
- Volunteers
- 260 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Angina Pectoris, Acute Coronary Syndrome
Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19
Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure…
- Conditions
- Angina Pectoris, Acute Coronary Syndrome, Coronary Syndrome, Coronary Artery Disease
- Trial name
- eCardioCovid19 (NCT04325867)
- Testing
- Tele-medicine platform
- Where
- 2 sites in Romania
- Volunteers
- 200 people
- Sponsor
- Professor Adrian Covic
Atherosclerosis, Stroke
Carotid Revascularization Endarterectomy Versus Stenting Trial
The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of…
- Conditions
- Atherosclerosis, Stroke, Carotid Stenosis, Cerebral Infarction
- Trial name
- CREST (NCT00004732)
- Testing
- Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
- Where
- 115 sites in United States, Canada
- Volunteers
- 2,502 people
- Sponsor
- Rutgers, The State University of New Jersey