Clinical Research Directory

Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon. DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained. Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.

Drug-Eluting Balloon Registry in Routine Clinical Practice

The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis

By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility/pivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.

DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis

The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are: 1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons? 2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?

1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI. Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial. In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients. In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.