Ischaemic Heart DiseaseDCBNORWICHNCT03603210
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015
An observational study of Ischaemic Heart Disease, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Drug coated balloon angioplasty
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2017to 23 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All comers, real life patients
Who may be able to join
- All patients who were treated with drug coated balloon angioplasty during 01/01/2009 - 31/12/2015 at Norfolk and Norwich University Hospital.
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
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.
Read the 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
- Being tested
- Drug coated balloon angioplasty
- Keywords
- Ischaemic heart disease, coronary angioplasty, drug coated balloons (DCB)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug coated balloon angioplastyDevice
Also called DCB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Drug coated balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
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).
Measured: 12 months and then up to 10 years
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).
Measured: 12 months and then up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start18 Sep 2017
- Primary completion23 Dec 2031 (estimated)
- Study completion23 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Upul Wickramarachchi, Dr, Principal investigator, Norfolk & Norwich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603210
- Sponsor's protocol ID
- 195002 (167-10-15)
- Acronym
- DCBNORWICH
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2017
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40406647Merinopoulos 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.
PubMed 37045498
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015
- ClinicalTrials.gov ID
- NCT03603210
- Acronym / sponsor ID
- DCBNORWICH / 195002 (167-10-15)
- Conditions
- Ischaemic Heart Disease
- Keywords
- Ischaemic heart disease, coronary angioplasty, drug coated balloons (DCB)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 23 Dec 2031 (estimated)
- Study completion
- 23 Dec 2031 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with DCB angioplasty | – | Device: Drug coated balloon angioplastyPatient 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All comers, real life patients
Key inclusion criteria (2 listed)
- All patients who were treated with drug coated balloon angioplasty during 01/01/2009 - 31/12/2015 at Norfolk and Norwich University Hospital.
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug coated balloon angioplastyAlso: DCBDrug 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. | Device | Patients treated with DCB angioplasty |
Primary outcome
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
Time frame: 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)
Time frame: 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).
Target Vessel Revascularisation (TVR)
Time frame: 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.
2 secondary outcomes
Acute vessel closure and target lesion revascularisation for 12 months and then up to 10 years.
Time frame: 12 months and then up to 10 years
TLR
Time frame: 12 months and then up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 40406647Merinopoulos 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.
- Derived from this study: PubMed 37045498Merinopoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Upul Wickramarachchi, Dr principal investigator
Norfolk & Norwich University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Heart Disease, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months and then up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603210, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.