Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04482972
• Collaborator: University of East Anglia (Other)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 216
• Patients Per Site Per Month: 46.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: DCB; Procedure: DES

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Nov 15, 2019
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
DCB DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)	Procedure: DCB; Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.
DES DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)	Procedure: DES; Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [Through study completion, an average of 10 years]

   All cause death will be defined as death due to any cause

Secondary Outcome Measures

1. Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR [Through study completion, an average of 10 years]

   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).

2. Cardiac rehospitalisation [Through study completion, an average of 10 years]

   Any hospital record of admission due to cardiac complications

3. Composite of cardiac death and cardiac rehospitalisation [Through study completion, an average of 10 years]

   Any hospital record of admission and death due to cardiac complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patients with coronary artery disease being treated with DCB or DES

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk	United Kingdom	NR4 7UY

Sponsors and Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust
• University of East Anglia

Investigators

• Principal Investigator: Simon C Eccleshall, Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.

• Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04482972
• Other Study ID Numbers: 195002
• First Posted: Jul 23, 2020
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust: Drug coated balloon; Drug eluting stent
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Apr 1, 2022