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Coronary DiseasePhase 4NCT00140530

Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)

A Phase 4 study testing Paclitaxel-eluting stent (Taxus) and Rapamycin-eluting stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 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 study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Paclitaxel-eluting stent (Taxus) and Rapamycin-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
2 sitesGermany
Study dates
Mar 2004to Jun 2005
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 at least 18 years old
  • Stable or unstable angina or a positive stress test
  • "de novo" coronary artery lesions
  • Written informed consent

Who cannot join

  • Myocardial infarction within 48 h. before enrollment
  • Target lesion located in left main trunk
  • Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Deutsches Herzzentrum Muenchen

    Munich, 80636

  • First Medizinische Klinik, Klinikum rechts der Isar

    Munich, 81675

Other trials in Germany

About this study

Official title: A Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Prevention of Restenosis (ISAR-TEST-1)

The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.

Read the detailed description

Drug-eluting stents represent a major advance in the treatment of restenosis. They have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtained in various patient subsets, these devices are now used in almost 90% of the stent implantation procedures performed in US hospitals. Along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data, concern has arisen regarding the safety of these devices. At the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents. A growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery. Recently, we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations. Using a porcine coronary model of restenosis, we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation. More recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. While the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable, their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated.

Comparison:

Polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents

Being tested
Paclitaxel-eluting stent (Taxus), Rapamycin-eluting stent
Medical subject headings
Coronary Disease

What participants receive

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

  • Paclitaxel-eluting stent (Taxus)Device

    Also called Taxus

    patients has been implanted the Paclitaxel-eluting stent.

  • Rapamycin-eluting stentDevice

    patients has been implanted the Rapamycin-eluting stent.

Study groups in NCT00140530
Study groupRoleWhat they receive
1ExperimentalDue to randomisation patients got a Paclitaxel-eluting stent
Receives: Device: Paclitaxel-eluting stent (Taxus)
2ExperimentalDue to randomization patients got a Rapamycin-eluting stent.
Receives: Device: Rapamycin-eluting stent

What is being measured

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

  1. In-stent late luminal loss

    Measured: 6 months

Secondary outcomes (2)

  1. Angiographic restenosis at follow-up angiography

    Measured: 6 months

  2. Need for target lesion revascularization due restenosis at 9 months

    Measured: 9 months

Timeline

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

  1. First posted1 Sep 2005 (estimated)
  2. Study startMar 2004
  3. Study completionJun 2005

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
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140530
Sponsor's protocol ID
GE IDE No. S02103
Other IDs
AZ 504/02
Status last verified
Jan 2008
First submitted
31 Aug 2005
Last updated
11 Jan 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23.

    PubMed 15975990

  • Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.

    PubMed 14724301

  • Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51. doi: 10.1161/01.cir.0000041632.02514.14.

    PubMed 12438288

  • Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.

    PubMed 14744976

  • Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3.

    PubMed 16391155

  • King L, Byrne RA, Mehilli J, Schomig A, Kastrati A, Pache J. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):E23-8. doi: 10.1002/ccd.24375. Epub 2012 May 4.

    PubMed 22431239

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paclitaxel-eluting stent (Taxus) and Rapamycin-eluting stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 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 4 inclusion and 3 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

In-stent late luminal loss (time frame: 6 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 NCT00140530, which also lists 6 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 11 Jan 2008.

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