At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Percutaneous coronary intervention using drug-coated balloon (device), Percutaneous coronary intervention using drug-eluting stent (device)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Percutaneous coronary intervention using drug-coated balloon — device: SeQuent Please (BBraun) + tailored antithrombotic regimen: 1. · Percutaneous coronary intervention using drug-eluting stent — device: Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic), Xience Pro S (Abbott) or Promus Elite (Boston Scientific) or any other DES can also be used provided that it has a CE mark for 1-month DAPT, combined with tailored antithrombotic regimen: 1.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 546
- Started
- 2022-09-01
- Last checked
- 2023-11
Plain English Summary
What is this study?
- • Testing a new treatment for coronary artery disease
- • NA - 546 participants
- • The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with coronary artery disease
Where?
- • Norwich - Norfolk and Norwich University Hospital Nhs Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
More detail
Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age ≥ 18 years
- ✓Informed written consent
- ✓At least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC)
- ✓Major Criteria
- ✓Long-term oral anticoagulation
Who cannot take part
- ✗Inability to give written consent
- ✗Reference diameter of the vessel is \<2.0mm or \>5.0 mm
- ✗Bifurcation lesion requiring the stenting of either of the branches after predilatation (TIMI\<3 or significant...
- ✗Dissection affecting the flow (TIMI\<3) or significant recoil (\>30% in the main epicardial vessel: LAD, LCX or RCA)...
- ✗in-stent restenosis
See the full criteria
Where Is This Study? (1 UK site)
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom
How to Get in Touch
Tuomas Rissanen, MD, PhD
Sponsor contactCONTACT
Alma Räsänen, MD
Sponsor contactCONTACT
