NCT03603210

Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Julie Dawson · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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.

Conditions

• Ischaemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Drug coated balloon angioplasty	Drug coated balloons are semi compliant percutaneous coronary angioplasty balloons coated with a chemotherapeutic drug such as Paclitaxel used with an excipient which allows rapid absorption to vessel wall upon balloon expansion for 30-60s. This allows coronary angioplasty without any permanent or semi- permanent stent or scaffold provided there are no vessel threatening dissections or significant acute recoil.

Timeline

• Start date: 2017-09-11
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2018-07-27
• Last updated: 2023-12-19

Locations

1 site across 1 country: United Kingdom