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

NCT03603210 | Active Not Recruiting

• 1 other identifier: 195002 (167-10-15)
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischaemic Heart Disease

Keywords

Ischaemic heart disease; coronary angioplasty; drug coated balloons (DCB)

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  12 months and then up to 10 years

• Myocardial Infarction (MI)

  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).

  12 months and then up 10 years

• 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.

  12 months and then up to 10 years

Secondary Outcomes (2)

• Acute vessel closure and target lesion revascularisation for 12 months and then up to 10 years.

  12 months and then up to 10 years

• TLR

  12 months and then up to 10 years

Study Arms (1)

Patients treated with DCB angioplasty

Patient cohort is comprised of all patients who received drug coated balloon angioplasty at NNUH during the above period. Within this cohort there will be two main groups which are drug coated balloon (DCB) angioplasty for de novo coronary artery disease (CAD) and DCB angioplasty for ISR/ST. Graft cases will be reported as a small third group. Outcomes will also be reported for three sub groups of de novo disease group, namely, dcb-only angioplasty for de novo disease, dcb-only angioplasty as primary percutaneous coronary intervention (PPCI) and dcb-only angioplasty group using a DCB with a diameter of 3mm or more in de novo disease.

Device: Drug coated balloon angioplasty

Interventions

Drug coated balloon angioplasty DEVICE

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.

Also known as: DCB

Patients treated with DCB angioplasty

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All comers, real life patients

You may qualify if:

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

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (2)

• Merinopoulos I, Corballis N, Gunawardena T, Bhalraam U, Natarajan R, Reinhold J, Wickramarachchi U, Maart C, Sawh C, Sulfi S, Gilbert T, Wistow T, Ryding A, Vassiliou VS, Eccleshall SC. Assessment of Scoring Balloons in STEMI Patients Treated With DCB-Only Angioplasty: A Single Center Study. Health Sci Rep. 2025 May 21;8(5):e70839. doi: 10.1002/hsr2.70839. eCollection 2025 May.

  PMID: 40406647 DERIVED

• Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, Reinhold J, Wickramarachchi U, Maart C, Gilbert T, Richardson P, Sulfi S, Sarev T, Sawh C, Wistow T, Ryding A, Mohamed MO, Perperoglou A, Mamas MA, Vassiliou VS, Eccleshall SC. Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI. JACC Cardiovasc Interv. 2023 Apr 10;16(7):771-779. doi: 10.1016/j.jcin.2023.01.380.

  PMID: 37045498 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Upul Wickramarachchi, Dr

  Norfolk & Norwich University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: July 27, 2018
• Study Start: September 11, 2017
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)