NCT04079192

Brief Summary

The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
5 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

August 27, 2019

Last Update Submit

August 9, 2022

Conditions

Coronary Artery DiseaseIn-Stent Restenosis

Keywords

Drug-Coated Balloon

Outcome Measures

Primary Outcomes (1)

  • Percent Diameter Stenosis (DS)

    Percent DS of the target segment assessed by quantitative coronary angiography (QCA)

    6 months

Secondary Outcomes (2)

  • Target lesion failure

    1 month, 6 months, 1 year and 2 years

  • Target vessel failure

    1 month, 6 months, 1 year and 2 years

Study Arms (2)

Biolimus A9™ Drug Coated Balloon

EXPERIMENTAL

Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Biolimus A9™ Drug Coated Balloon

Device: Biolimus A9 Drug Coated Balloon

Sequent ® Please Paclitaxel coated balloon

ACTIVE COMPARATOR

Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Sequent ® Please Paclitaxel coated balloon

Device: SeQuent Please Paclitaxel Drug Coated Balloon

Interventions

Biolimus A9 Drug Coated BalloonDEVICE

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Biolimus A9™ Drug Coated Balloon
SeQuent Please Paclitaxel Drug Coated BalloonDEVICE

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Sequent ® Please Paclitaxel coated balloon

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or \> 90% stenosis.
  • Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
  • Patient has provided written informed consent
  • Age ≥ 18 years.
  • Patient is willing and able to comply with the study procedures and follow-up.

You may not qualify if:

  • Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
  • Patient with acute cardiac decompensation or acute cardiogenic shock
  • Documented left ventricular ejection fraction (LVEF) ≤ 30%
  • Patient with impaired renal function (glomerular filtration rate \< 80 mL/min/1.73 m2).
  • More than 2 epicardial vessels requiring revascularization
  • Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
  • Patient has an ISR lesion that cannot be covered with one DCB length.
  • Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
  • Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
  • Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
  • Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
  • Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
  • Anticipated difficulties to complete the angiographic follow-up study.
  • Patient with a life expectancy of less than 12 months.
  • Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Heart Center, Segeberger Kliniken

Bad Segeberg, Germany

Location

Heart Center Leipzig - University of Leipzig

Leipzig, Germany

Location

Evangelisches Krankenhaus Paul Gerhardt Stift

Wittenberg, Germany

Location

Mater Private Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario de La Princesa

Madrid, Spain

Location

Royal Bournemouth hospital

Bournemouth, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Craigavon Cardiac Centre

Craigavon, United Kingdom

Location

Dorset County Hospital

Dorchester, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, United Kingdom

Location

Related Publications (2)

  • Byrne RA, Hahn JY, O'Kane P, Sabate M, Toelg R, Copt S, Fitzgerald S, Morice MC, Trevelyan J, Mylotte D, Ortiz AF, Rai H, Durand R, Wohrle J, Kleber FX, Stefanini G, Alfonso F. Randomized Trial of Biolimus DCB for In-Stent Restenosis: The Primary Results of the REFORM Study. JACC Cardiovasc Interv. 2025 Mar 10;18(5):654-662. doi: 10.1016/j.jcin.2024.11.026. Epub 2025 Feb 5.

    PMID: 39918494DERIVED

  • Traynor BP, Fitzgerald S, Alfonso F, O'Kane P, Sabate M, Tolg R, Trevelyan J, Hahn JY, Mylotte D, Wohrle J, Rai H, Cortese B, Morice MC, Schuette D, Copt S, Oldroyd KG, Byrne RA; REFORM investigators. Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9 drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM). Cardiovasc Revasc Med. 2023 Nov;56:75-81. doi: 10.1016/j.carrev.2023.06.004. Epub 2023 Jun 6.

    PMID: 37328392DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robert A Byrne, MD, PhD

    Mater Private Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The subject will be blinded to the study treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients who meet all the eligibility criteria will be randomized 2:1 to receive treatment with either a BA9-DCB or a Sequent Please® Paclitaxel Coated Balloon.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 6, 2019

Study Start

August 7, 2020

Primary Completion

April 1, 2023

Study Completion

April 1, 2024

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)IE(2)GB(6)IT(1)ES(3)