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

Active, not recruiting

• Conditions: Ischaemic Heart Disease

• Registration Number: NCT03603210
• Lead Sponsor: Julie Dawson

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.

Study Timeline

• Study Start: 2017-09-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Vessel Revascularisation (TVR)	12 months and then up to 10 years	A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
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	12 months and then up to 10 years	Death. All cause death will be defined as death due to any cause.; . Target vessel revascularisation (TVR) A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
Myocardial Infarction (MI)	12 months and then up 10 years	An MI is defined as an episode of chest pain with positive cardiac enzyme troponin as per MINAP definition (a hospital diagnosis reported as a troponin positive MI).

Secondary Outcome Measures

Name	Time	Method
Acute vessel closure and target lesion revascularisation for 12 months and then up to 10 years.	12 months and then up to 10 years	Acute Vessel Closure Acute vessel closure is defined as an event where a patient had to be taken back to cardiac catheterisation lab and require repeat angioplasty (during the same hospital stay) for a complete or partial occlusion of the artery due to a dissection.; TLR A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment).
TLR	12 months and then up to 10 years	A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment).

Trial Locations

Locations (1)

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, Norfolk, United Kingdom