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Coronary RestenosisISAR-DESIRE 3ANCT02367495

Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

A study testing PCB in people with Coronary Restenosis, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Restenosis
What is being tested?
PCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteGermany
Study dates
Jan 2015to 25 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Deutsches Herzzentrum Muenchen

    Munich, Bavaria, 80636

Other trials in Germany

About this study

Official title: Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue Drug-eluting Coronary Stents

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)

Read the detailed description

The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.

Being tested
PCB
Keywords
Coronary Restenosis, restenosis, paclitaxel-coated balloon, drug-eluting stent, drug-coated balloon, coronary angiography
Medical subject headings
Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCBDevice

    PCB with Citrate-based excipient

Study groups in NCT02367495
Study groupRoleWhat they receive
PCBExperimentalPaclitacel-coated balloon (Agent, Boston Scientific)
Receives: Device: PCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment percent diameter stenosis (%DS)

    Measured: at 6-8 months

Secondary outcomes (3)

  1. In-segment minimal lumen diameter and binary restenosis

    Measured: at 6-8 months

  2. Composite of death or myocardial infarction

    Measured: at 12 months

  3. Target lesion revascularization and thrombosis

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completion25 Oct 2017
  4. Study completion25 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367495
Sponsor's protocol ID
GE IDE No.S03814
Acronym
ISAR-DESIRE 3A
Status last verified
Jan 2019
First submitted
13 Feb 2015
Last updated
8 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39290129

  • 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.

    PubMed 34791755

Questions about this trial

What is this clinical trial studying?

A study testing PCB in people with Coronary Restenosis, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jan 2019. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

In-segment percent diameter stenosis (%DS) (time frame: at 6-8 months). 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 NCT02367495, 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 Jan 2019.

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