NCT02367495

Brief Summary

Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

February 13, 2015

Last Update Submit

January 7, 2019

Conditions

Coronary Restenosis

Keywords

Coronary Restenosisrestenosispaclitaxel-coated balloondrug-eluting stentdrug-coated ballooncoronary angiography

Outcome Measures

Primary Outcomes (1)

  • In-segment percent diameter stenosis (%DS)

    at 6-8 months

Secondary Outcomes (3)

  • In-segment minimal lumen diameter and binary restenosis

    at 6-8 months

  • Composite of death or myocardial infarction

    at 12 months

  • Target lesion revascularization and thrombosis

    at 12 months

Study Arms (1)

PCB

EXPERIMENTAL

Paclitacel-coated balloon (Agent, Boston Scientific)

Device: PCB

Interventions

PCBDEVICE

PCB with Citrate-based excipient

PCB

Eligibility Criteria

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

You may qualify if:

  • Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
  • Written, informed consent by the patient for participation in the study.
  • In women with childbearing potential a negative pregnancy test is mandatory.

You may not qualify if:

  • Age \< 18 years
  • Cardiogenic shock
  • Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  • Target lesion located in the left main trunk or bypass graft.
  • Target lesion located in small vessel (vessel size \< 2.0 mm)
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  • Contraindications to antiplatelet therapy, paclitaxel
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, Bavaria, 80636, Germany

Location

Related Publications (2)

  • Koch T, Lenz T, Rheude T, Cassese S, Xhepa E, Joner M, Mehilli J, Schunkert H, Kastrati A, Kufner S. Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis. Catheter Cardiovasc Interv. 2024 Nov;104(5):909-917. doi: 10.1002/ccd.31228. Epub 2024 Sep 18.

    PMID: 39290129DERIVED

  • Kufner S, Rai H, Wiebe J, Altevogt F, Pyxaras S, Joner M, Xhepa E, Cassese S, Colleran R, Schunkert H, Zrenner B, Kastrati A, Byrne RA; Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3A (ISAR-DESIRE 3A) Investigators. A prospective trial of a novel low-dose paclitaxel-coated balloon therapy in patients with restenosis in drug-eluting coronary stents Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-stent REstenosis 3A (ISAR-DESIRE 3A). Catheter Cardiovasc Interv. 2022 Feb;99(3):754-762. doi: 10.1002/ccd.30014. Epub 2021 Nov 18.

    PMID: 34791755DERIVED

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Robert Byrne, MB BCh PhD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 20, 2015

Study Start

January 1, 2015

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

DE(1)