Clinical trials: In-stent Restenosis
Coronary Instent Restenosis
A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent
The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon…
- Trial name
- PEPCAD (NCT01622075)
- Testing
- SeQuent® Please, Taxus Liberte
- Where
- China
- Volunteers
- 220 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Cerebrovascular Disease
Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis
The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery (MCA) M1 segment
- Trial name
- NCT01558245
- Testing
- tissue kallikrein
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Jinling Hospital, China
Coronary Stenosis
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple…
- Trial name
- NCT00301522
- Testing
- TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation, Express2
- Where
- 72 sites in United States
- Volunteers
- 1,108 people
- Sponsor
- Boston Scientific Corporation
Ischemic Heart Disease, Restenosis
Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial
The use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified.
- Trial name
- SINGLEKISS (NCT00798954)
- Testing
- Sirolimus-eluting coronary stent (Cypher), Paclitaxel-eluting stent (TAXUS)
- Where
- 17 sites in Japan
- Volunteers
- 800 people
- Sponsor
- Vulnerable Plaque Society
Restenosis or Adverse Cardiovascular Event
Endothelial Function and Heart Rate Variability After Stenting
The objective of this study is to evaluate whether impaired endothelial function and low heart rate variability are associated with clinical restenosis after percutaneous coronary intervention with stent implantation in patients…
- Trial name
- FUNKIS (NCT00999323)
- Testing
- stent implantation in coronary artery
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helse Stavanger HF
In-stent Coronary Artery Restenosis
In-stent Restenosis in Patients With Patent Previous Bare Metal Stent
Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis within previously deployed stent, is most…
- Trial name
- NCT01296399
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Rambam Health Care Campus
Stent Restenosis, Coronary Artery Disease
Exercise Training in Coronary Artery Disease Patients After Stenting
To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional…
- Trial name
- NCT05591365
- Testing
- Structured In-Patient and Home plan, Conventional Therapy
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- Riphah International University
In-stent Arterial Restenosis
Paclitaxel Eluting Balloon for SFA In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.
- Trial name
- NCT01616888
- Testing
- PTA with drug eluting balloon with paclitaxel
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto
In-stent Restenosis
DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
- Trial name
- NCT01127958
- Testing
- PCI with a drug-eluting balloon, PCI with a drug-eluting stent
- Where
- 8 sites in Netherlands
- Volunteers
- 270 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary…
- Conditions
- Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome, MINOCA, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- Trial name
- OCT-AGEM (NCT07182799)
- Testing
- Plaque vulnerability assessment, Stent implantation optimization
- Where
- Italy
- Volunteers
- 3,200 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent
The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control…
- Conditions
- Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary, Stents
- Trial name
- MARTIN (NCT00637104)
- Testing
- Mar-Tyn TiN coated Co-Cr Numen stent implant, Vision Co-Cr stent implant
- Where
- 7 sites in Germany, Italy and 2 more
- Volunteers
- 160 people
- Sponsor
- International Biomedical Systems S.p.A.
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, 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
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
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