Clinical trials: Restenosis, Coronary
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, Type 2 Diabetes Mellitus
Comparison Between Pioglitazone and SES With type2 DM
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents.
- Trial name
- NCT00482183
- Testing
- Pioglitazone
- Volunteers
- 38 people
- Sponsor
- Showa University
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 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
Coronary Artery Disease
Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents
For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.
- Trial name
- DESIRE-2 (NCT00598715)
- Testing
- Sirolimus eluting stent, Paclitaxel-eluting stent
- Where
- 2 sites in Germany
- Volunteers
- 450 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Calcification, Intravascular Lithotripsy
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis
- Trial name
- DRAGON (NCT06276114)
- Testing
- Stent Underexpansion
- Where
- 20 sites in Italy, Poland
- Volunteers
- 121 people
- Sponsor
- Medical University of Silesia
Cardiovascular Diseases
Investigating the Effects of Dietary Nitrate on Vascular Function, Platelet Reactivity and Restenosis in Stable Angina
The mainstay treatment for reducing the symptoms of angina and long-term risk of heart attacks in patients with heart disease is stent implantation in the diseased coronary artery.
- Trial name
- NITRATE-OCT (NCT02529189)
- Testing
- Beetroot Juice
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Queen Mary University of London
Coronary Stenosis
FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions (FADDY)
Drug-eluting stent (DES) has been the primary choice for in suit coronary lesions treatment. In comparison to bare-metal stent (BMS), it evidently decreases the rate of restenosis.
- Trial name
- FADDY (NCT03452904)
- Testing
- Drug-coated balloon, Drug-eluting stent
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Artery Disease, Left Main Coronary Artery Stenosis
Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above…
- Conditions
- Coronary Artery Disease, Left Main Coronary Artery Stenosis, Left Main Coronary Artery Disease, Restenosis, Coronary
- Trial name
- iLITRO (NCT03767621)
- Testing
- Indication of revascularization
- Where
- 38 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease, Coronary Stenosis
Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease
- Trial name
- ULTRA (NCT05205148)
- Testing
- Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Angina Pectoris, Coronary Artery Disease
A Safety Study of ABI-007 for In-Stent Restenosis
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries.
- Trial name
- NCT00093223
- Testing
- Paclitaxel Nanoparticle Albumin Bound
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Celgene
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD)
Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group…
- Conditions
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD), De Novo Stenosis
- Trial name
- DEBATE (NCT05516446)
- Testing
- DEB for de Novo Lesions, DES for de Novo Lesions
- Where
- Tunisia
- Volunteers
- 290 people
- Sponsor
- General Administration of Military Health, Tunisia
Coronary Restenosis
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
- Trial name
- NCT03242096
- Testing
- Sirolimus coated balloon, Paclitaxel coated balloon
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 50 people
- Sponsor
- InnoRa GmbH
Acute Coronary Syndrome, Angina Pectoris
Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity.
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Trial name
- BIO-RESORT (NCT01674803)
- Testing
- Orsiro, Synergy, Resolute Integrity
- Where
- Netherlands
- Volunteers
- 3,514 people
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
Coronary Artery Disease
Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries
Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough…
- Trial name
- NCT00732953
- Testing
- Genous stent implantation with paclitaxel-eluting balloon dilation, Genous stent implantation
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- University of Ulm
Coronary Restenosis
Oral Sirolimus for In-Stent Restenosis
Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue.
- Trial name
- OSIRIS (NCT00859183)
- Testing
- Sirolimus
- Where
- 3 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Disease, Coronary Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- XIENCE V India (NCT00631228)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- 18 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices