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Heart DiseasePhase 4ISAR-DESIRE-3NCT00987324

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

A Phase 4 study testing Taxus stent, SeQuent Please and Conventional Balloon Catheter in people with Heart Disease and Ischemia, run by Deutsches Herzzentrum Muenchen at 3 sites 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

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease, Ischemia, Restenosis
What is being tested?
Taxus stent, SeQuent Please and Conventional Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
3 sitesGermany
Study dates
Jul 2009to Oct 2013
Phase
Phase 4
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 or her/his legally-authorized representative 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, stainless steel, cobalt, chrome.
  • 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

3 sites in 1 country.

Germany3 sites

  • Herz-Zentrum

    Bad Krozingen, 79189

  • 1. Med. Klinik, Klinikum rechts der Isar

    Munich, Bavaria, 81675

  • Deutsches Herzzentrum

    Munich, 80636

Other trials in Germany

About this study

Official title: Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Read the detailed description

The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus.

Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions.

The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

Being tested
Taxus stent, SeQuent Please, Conventional Balloon Catheter
Medical subject headings
Heart Diseases, Ischemia

What participants receive

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

  • Taxus stentDevice

    Implantation of paclitaxel-eluting stent

  • SeQuent PleaseDevice

    Dilation with SeQuent Please (paclitaxel-eluting balloon)

  • Conventional Balloon CatheterDevice

    Ryuijin, Trek

Study groups in NCT00987324
Study groupRoleWhat they receive
Paclitaxel-eluting stentExperimentalPaclitaxel-eluting stent (Taxus)
Receives: Device: Taxus stent
Plain BalloonActive comparatorplain balloon angioplasty
Receives: Device: Conventional Balloon Catheter
Paclitaxel-eluting balloonExperimentalSeQuent Please
Receives: Device: SeQuent Please

What is being measured

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

  1. Percent in-segment diameter stenosis at follow-up angiography

    Measured: 6-8 months

Secondary outcomes (4)

  1. In-segment minimal luminal diameter

    Measured: 6-8 months

  2. In-segment binary angiographic restenosis

    Measured: 6-8 months

  3. Combined incidence of death or myocardial infarction

    Measured: 1 and 2 years

  4. Incidence of thrombosis

    Measured: 1 and 2 years

Timeline

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

  1. First posted30 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2012
  4. Study completionOct 2013

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00987324
Sponsor's protocol ID
GE IDE NO. S02908
Acronym
ISAR-DESIRE-3
Status last verified
Nov 2016
First submitted
27 Aug 2009
Last updated
21 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

    PubMed 19487593

  • Giacoppo D, Alvarez-Covarrubias HA, Koch T, Cassese S, Xhepa E, Kessler T, Wiebe J, Joner M, Hochholzer W, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. 2023 Apr 17;44(15):1343-1357. doi: 10.1093/eurheartj/ehad026.

    PubMed 36807512

  • Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv. 2015 Jun;8(7):877-84. doi: 10.1016/j.jcin.2015.01.031. Epub 2015 May 20.

    PubMed 26003022

  • Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1.

    PubMed 23206837

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Taxus stent, SeQuent Please and Conventional Balloon Catheter in people with Heart Disease and Ischemia, run by Deutsches Herzzentrum Muenchen at 3 sites 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percent in-segment diameter stenosis at follow-up angiography (time frame: 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 NCT00987324, which also lists 4 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 21 Nov 2016.

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