Clinical trial NCT04482972: Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty
Official title: Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Drug coated balloon
Drug eluting stent
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2020-07-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Norfolk and Norwich University Hospitals NHS foundation trust

Brief summary: Drug coated balloon (DCB) is a relatively new technology which allows the treatment of coronary artery disease without permanent implantation of a metallic scaffold (stent) in the coronary artery. It is recommended by international guidelines for the treatment of in-stent restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings again). Data on patient outcomes of patients treated with DCB for de novo coronary artery disease (narrowings in artery supplying blood to the heart that has not been previously treated with a stent) are limited to relatively small studies. In our institution, DCBs have been used over the last 10 years and we have developed a large clinical database. We intend to compare the outcomes of all our patients treated clinically with DCB vs patients treated with drug eluting stent (DES). We will, incorporate all patients presenting either with myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1) mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac mortality and cardiac rehospitalisation


Eligibility criteria: Patients with coronary artery disease being treated with DCB or DES

Primary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
measure: Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR
timeFrame: Through study completion, an average of 10 years
measure: Cardiac rehospitalisation
timeFrame: Through study completion, an average of 10 years
measure: Composite of cardiac death and cardiac rehospitalisation
timeFrame: Through study completion, an average of 10 years
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Simon C Eccleshall
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.