NCT01781546

Brief Summary

The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
220

participants targeted

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

Timeline
Completed

Started May 2013

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
terminated

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

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

May 22, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

4.7 years

First QC Date

January 29, 2013

Last Update Submit

January 28, 2018

Conditions

Coronary Artery Disease

Keywords

drug eluting balloonbare metal stentcoronary artery diseaseacute coronary syndromepercutaneous coronary interventionDEBBMS

Outcome Measures

Primary Outcomes (2)

  • MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR))

    In stable patients, the evidence of ischemia is acquired either by non-invasive testing (for example stress ECG or perfusion imaging) or by pressure wire measurement (FFR) during coronary angiography.

    At 9 months

  • ID-TLR (Ischemia Driven Target Lesion Revascularisation)

    at 36 months

Secondary Outcomes (2)

  • ID-TLR (Ischemia Driven Target Lesion Revascularisation)

    At 9 months

  • Failure to treat the lesion

    During PCI

Other Outcomes (3)

  • Control angiography and OCT imaging

    At 6 months

  • MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR))

    at 36 months

  • ID-TLR (Ischemia Driven Target Lesion Revascularisation)

    at 36 months

Study Arms (2)

drug-eluting balloon (DEB)

EXPERIMENTAL

Patients treated with drug-eluting balloon (DEB). Provisional stenting with BMS is permitted in case of a flow-limiting dissection or significant recoil (\>30% in main branch and \>50% side-branch), Includes both stable CAD and ACS patients.

Procedure: drug-eluting balloon (DEB)

bare-metal stent (BMS)

ACTIVE COMPARATOR

Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.

Procedure: bare-metal stent (BMS)

Interventions

drug-eluting balloon (DEB)PROCEDURE

The length of the DEB is chosen so that the lesion and 2mm from both ends are covered by the DEB. If needed, several DEBs can be used to cover the whole lesion. The diameter of the DEB and the pressure used is chosen so that the balloon-artery -ratio is 0.8-1.0. In case of a flow limiting dissection, significant recoil or coronary perforation, a provisional BMS is implanted (stent-artery -ratio 1.1) and the post dilatation is performed if indicated (the lesion length is \>20mm or stent malapposition is suspected).

Also known as: SeQuent Please (B Braun, Germany, diameter 2,5-4.0mm)
drug-eluting balloon (DEB)
bare-metal stent (BMS)PROCEDURE

The BMS is implanted after predilatation (stent-artery -ratio 1.1) to cover the whole lesion and the postdilatation is performed if indicated (the lesion length \>20mm or stent malapposition is suspected).

Also known as: Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)
bare-metal stent (BMS)

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Informed written consent
  • At least one of the following
  • Patient is using oral anticoagulation (warfarin, dabigatran or rivaroxaban)
  • Anemia (hemoglobin below the threshold: \< 117g/l in women and \< 134 g/l in men) or thrombocytopenia (\<100) detected \<6 months prior the PCI
  • Active malign disease (metastatic cancer or ongoing radio- or chemotherapy)
  • Prior intracerebral hemorrhage or ischemic stroke
  • Severe kidney or liver dysfunction (eGFR \< 30ml/kg/min, liver cirrhosis, BIL \>2x over threshold or ALAT \>3x over threshold)
  • Elective surgery planned \< 12 months after the PCI
  • General frailty for e.g. because of long corticosteroid treatment or generalized cachexia (BMI \< 20 kg/m2)
  • Age ≥ 80 years
  • Inability or suspected inability to use DAPT for 12 months
  • Either of the following:
  • \) Prior bleeding (BARC 2-5)
  • Stable angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. Ischemia is documented by the pressure wire measurement (FFR) or by a non-invasive test such as stress ECG test or perfusion imaging
  • +4 more criteria

You may not qualify if:

  • Inability to give written consent
  • STEMI
  • Reference diameter of the vessel is \<2,5mm or \>4,0mm
  • Bifurcation lesion requiring the stenting of the side branch
  • Dissection affecting the flow (TIMI\<3) or significant recoil (\>30% in main branch, \>50% in side branch) after predilatation
  • In-stent restenosis
  • Life expectancy \< 12 months
  • Cardiogenic shock at the arrival to the coronary angiography
  • Uncertainty about neurological recovery e.g. after resuscitation
  • Unprotected left main (LM) lesion
  • Chronic total occlusion (CTO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Hospital Heart Center

Helsinki, Finland

Location

North Karelia Central Hospital

Joensuu, 80210, Finland

Location

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

  • Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.

    PMID: 31204115DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Tuomas Rissanen, MD, PhD

    North Karelia Central Hospital

    PRINCIPAL INVESTIGATOR

  • Antti Siljander, MD

    North Karelia Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, MD, PhD

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

May 22, 2013

Primary Completion

January 16, 2018

Study Completion

January 16, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

FI(4)