Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

Coronary Artery Disease Clinical Trial

Official title:

Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482972
• Other study ID #: 195002
• Status: Recruiting
• Start date: September 11, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: Simon C Eccleshall, MRCP, MD
• Phone: 00441603286286
• Email: Simon.eccleshall[@]nnuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years
• Eligibility: Patients with coronary artery disease being treated with DCB or DES

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• DCB
Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.
• DES
Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust	University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All cause death will be defined as death due to any cause	Through study completion, an average of 10 years
Secondary	Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR	An MI is defined as per MINAP definition (a hospital diagnosis reported as a troponin positive MI). 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.; 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.; 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).	Through study completion, an average of 10 years
Secondary	Cardiac rehospitalisation	Any hospital record of admission due to cardiac complications	Through study completion, an average of 10 years
Secondary	Composite of cardiac death and cardiac rehospitalisation	Any hospital record of admission and death due to cardiac complications	Through study completion, an average of 10 years