Clinical trials: Stent
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb…
- Trial name
- MERLION (NCT04073121)
- Testing
- Luminor DCB and Angiolite DES
- Where
- 2 sites in Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Coronary Artery Disease
Effects of a rapamycIn-eluting carboNized Stent With a Completely biodEgradable polymeR Coating
Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to the occurrence of major adverse cardiac…
- Trial name
- INERT (NCT01981304)
- Volunteers
- 50 people
- Sponsor
- University of Roma La Sapienza
Abdominal Aortic Aneurysm
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac…
- Trial name
- ARBITER-II (NCT00442065)
- Testing
- Aorfix™ Stent Grafts (AAA endovascular procedure)
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Lombard Medical
Coronary Artery Disease
Hydroxyapatite Active Pro Healing Clinical Trial Program
The purpose of this first feasibility study is to evaluate the performance of Vesta™ \& VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions.
- Trial name
- HApFIM (NCT00474084)
- Testing
- Intravascular Coronary Stent
- Volunteers
- 70 people
- Sponsor
- BioSync Scientific Pvt. Ltd.
Coronary Artery Disease
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting…
- Trial name
- DEBSCAN-IVL (NCT06657833)
- Testing
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon, Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
- Where
- 15 sites in Netherlands, Spain
- Volunteers
- 128 people
- Sponsor
- Fundación EPIC
Renal Artery Stenosis
Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.
- Trial name
- RADAR (NCT00640406)
- Testing
- Dynamic Renal Stent plus Best Medical Treatment, Best Medical Treatment
- Where
- Germany
- Volunteers
- 86 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in…
- Trial name
- NCT01140204
- Testing
- Implantation of a bare metal stent
- Where
- 2 sites in Germany
- Volunteers
- 32 people
- Sponsor
- University Hospital, Saarland
Coronary Artery Disease
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
- Trial name
- DESSOLVE-I (NCT01247428)
- Testing
- MiStent SES
- Where
- 5 sites in Australia, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Micell Technologies
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral…
- Trial name
- SKYWARD TF (NCT07512128)
- Testing
- Carotid Intravascular Lithotripsy
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease
OPTImal Management of Antithrombotic Agents: OPTIMA-2 Trial
High on-treatment platelet reactivity (HOPR) is associated with increased risk of cardiovascular events in patients undergoing percutaneous coronary intervention (PCI).
- Trial name
- OPTIMA-2 (NCT01955200)
- Testing
- Clopidogrel, Cilostazol, Ticagrelor
- Where
- China
- Volunteers
- 1,724 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Coronary Artery Disease
RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
- Trial name
- NCT03584464
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Where
- 25 sites in United States, Belgium and 2 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Vascular
Coronary Artery Stenosis
Cordimax China Post Market Surveillance
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the…
- Trial name
- NCT03185221
- Testing
- Cordimax, XIENCE V
- Where
- China
- Volunteers
- 3,660 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Malignant Biliary Obstruction, Biliary Tract Neoplasms
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for…
- Conditions
- Malignant Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Cancer Non-resectable
- Trial name
- CARPEGIEM (NCT06375967)
- Testing
- Endoscopic biliary drainage, Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Where
- 10 sites in Spain
- Volunteers
- 128 people
- Sponsor
- Hospital Universitari de Bellvitge
Carotid Artery Diseases
TCAR Cerebral Protection And MicroNET-Covered Stent To Reduce Strokes
Prospective, single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention.
- Trial name
- TOP-GUARD (NCT04547387)
- Testing
- Trans-carotid access revascularization with MicroNET covered stent implantation
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer
Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer.
- Trial name
- NCT02646514
- Testing
- Radiofrequency ablation with stenting, stenting
- Where
- South Korea
- Volunteers
- 48 people
- Sponsor
- Yonsei University
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Acute Kidney Injury, Acute Renal Failure
Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy
Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence.
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Acute Renal Injury
- Trial name
- Mozart-II (NCT02743156)
- Testing
- IVUS-guided PCI, Angiography-guided PCI
- Where
- 2 sites in Brazil, Spain
- Volunteers
- 300 people
- Sponsor
- InCor Heart Institute
Wide Neck Intracranial Aneurysms
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
- Trial name
- NCT01753388
- Testing
- Liberty Stent
- Where
- 4 sites in Germany
- Sponsor
- Penumbra Inc.
Acute ST Segment Elevation Myocardial Infarction
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study
The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to…
- Trial name
- MASTER (NCT02828683)
- Testing
- PCI in patients with ST-elevation myocardial infarction
- Where
- 13 sites in Brazil, Italy and 3 more
- Volunteers
- 500 people
- Sponsor
- Terumo Europe N.V.
Coronary Artery Disease
Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis.
- Trial name
- COMPARE-II (NCT01233453)
- Testing
- the everolimus eluting ® stent, the Biolimus A9 eluting NOBORI® stent
- Where
- 11 sites in Greece, Netherlands and 2 more
- Volunteers
- 2,700 people
- Sponsor
- Maasstad Hospital