Clinical trials: In-Stent Restenosis
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
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, 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
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
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
Peripheral Vascular Disease
Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery
The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral…
- Trial name
- ISAR-PEBIS (NCT01083394)
- Testing
- PTA, PTA with PEB, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 2 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
In Stent Restenosis
DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is…
- Trial name
- DEB-DRAGON (NCT04415216)
- Testing
- percutaneous coronary intervention
- Where
- 9 sites in Poland
- Volunteers
- 1,369 people
- Sponsor
- Medical University of Silesia
In-stent Stenosis of Infrapopliteal Arteries
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb.
- Trial name
- BAIR (NCT01398033)
- Testing
- paclitaxel-coated balloon, non-coated balloon
- Where
- Germany
- Sponsor
- Herz-Zentrums Bad Krozingen
Stent Restenosis, Coronary Artery Disease
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting.
- Trial name
- NCT05315193
- Testing
- Structured In-patient and Home plan, Conventional Therapy
- Where
- Pakistan
- Volunteers
- 73 people
- Sponsor
- Riphah International University
Stent Thrombosis, Restenosis
Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis
Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST).
- Trial name
- NIVUS (NCT00647504)
- Where
- 5 sites in Denmark, Finland and 3 more
- Volunteers
- 450 people
- Sponsor
- Tampere University
Coronary Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 people
- Sponsor
- Abbott Medical Devices