Clinical trial NCT03603210: Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015
Official title: Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischaemic Heart Disease
Keywords: Ischaemic heart disease
coronary angioplasty
drug coated balloons (DCB)
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers, real life patients

Brief summary: This is a single center, retrospective, observational cohort study to assess the safety and efficacy of drug coated balloon (DCB) angioplasty in all forms of coronary artery disease. The Investigators intend to report outcomes of all patients who received DCB angioplasty at their center during the above mentioned period for up to 10 years.

Detailed description: The Investigators expect to assess outcomes of all patients who received Drug Coated Balloon Angioplasty treatment, which is a novel therapy as opposed to standard Drug Eluting Stent insertion, for all types of coronary artery disease from 01/01/2009 till 31/12/2015 in their center. The Investigators believe the number exceeds 1000 patients.

The Investigators plan to collect demographic and procedural data from their existing data base. They will request up to date follow-up events from NICOR (National Institute for Cardiovascular Outcomes Research, UK) in 2017(data ending December 2016), by which time all patientswould have had minimum of 12 months follow up. The Investigators plan to incorporate these findings to their data set and report the comprehensive outcomes. Primary end point will be major adverse cardiac outcomes (MACE) defined as a composite of death, myocardial infarction and target vessel revascularisation. Secondary end points will be acute vessel closure and target lesion revascularisation. The Investigators also have a long term plan of requesting follow-up events from NICOR for up to 10 years, so they can report on long term outcomes of drug coated balloon treatment.

Eligibility criteria: Inclusion Criteria:

All patients who were treated with drug coated balloon angioplasty during 01/01/2009 - 31/12/2015 at Norfolk and Norwich University Hospital.

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Exclusion Criteria:

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Primary outcomes:
measure: Major adverse cardiac events (MACE) defined as a composite of all cause death, myocardial infarction and target vessel revascularisation for 12 months and then up to 10 years
timeFrame: 12 months and then up to 10 years
measure: Myocardial Infarction (MI)
timeFrame: 12 months and then up 10 years
measure: Target Vessel Revascularisation (TVR)
timeFrame: 12 months and then up to 10 years
Secondary outcomes:
measure: Acute vessel closure and target lesion revascularisation for 12 months and then up to 10 years.
timeFrame: 12 months and then up to 10 years
measure: TLR
timeFrame: 12 months and then up to 10 years
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
Study officials:
affiliation: Norfolk & Norwich University Hospital
name: Upul Wickramarachchi, Dr
role: PRINCIPAL_INVESTIGATOR
References: