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AzTrials

Coronary DiseasePhase 4NCT00152308

Non-Polymer-Based, Rapamycin-Eluting Stents to Prevent Restenosis

A Phase 4 study testing 2% rapamycin-eluting YUKONdes PEARL-stent and 1% rapamycin-eluting YUKONdes PEARL-stent in people with Coronary Disease, run by Translumina GmbH at 10 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the effectively of coating of coronary stents with two different doses of rapamycin for the prevention of coronary vessel re-blockage Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Disease
What is being tested?
2% rapamycin-eluting YUKONdes PEARL-stent and 1% rapamycin-eluting YUKONdes PEARL-stent
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
10 sitesin 3 countries
Study dates
Dec 2004to Feb 2007
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-85 years; Symptoms (stable or unstable angina) or signs of myocardial ischemia; Single de novo diagnosed lesion in a native coronary artery (50-99% DS); Lesion length 8 - 25 mm; Vessel diameter 2.25-3.75 mm; Written informed consent

Who cannot join

  • Left main target lesion unprotected by a graft; Ostial and bifurcation target lesion; Severely calcified lesions; Thrombus in target lesion; Tortuosity or angulation of target vessel or lesion; Treatment of nontarget lesions in the same or a different coronary vessel during the index procedure; Contraindications to the study medications; Acute myocardial infarction (< 48 h); Left ventricular ejection fraction < 25%; Participation in another trial; Pregnancy or lack of protection against pregnancy during the study Coexisting conditions limiting the life expectancy to less 24 months or that could affect the compliance of patients with protocol; Serum creatinin >2.0mg/dL; Hemorrhagic diathesis; Leukocyte count <3500/ml^3 Platelet count <100.000/ml^3

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Austria4 sites

  • St. Johanns Spital

    Salzburg, 5020

  • Donauspital der Stadt Wien

    Vienna, 1020

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Wilhelminenspital der Stadt Wien

    Vienna, 1160

Other trials in Austria

Germany3 sites

  • Deutsches Herzzentrum Muenchen

    Munich, 80636

  • Kardiologische Praxis und Praxisklinik

    Munich, 81379

  • First Medizinische Klinik rechts der Isar

    Munich, 81675

Other trials in Germany

Israel3 sites

  • Hadassah University Hospital

    Jerusalem, 91120

  • Sourasky Medical Center

    Tel Aviv, 64239

  • Assaf Harofeh Medical Center

    Zrifin, 70300

Other trials in Israel

About this study

Official title: A Prospective, Placebo-Controlled, Double-Blind, Randomized Study Evaluating the Efficacy of Non-Polymer-Based Coating With Two Different Rapamycin-Dosages for the Prevention of Restenosis After Percutaneous Coronary Interventions

The purpose of the study is to evaluate the effectively of coating of coronary stents with two different doses of rapamycin for the prevention of coronary vessel re-blockage

Read the detailed description

In-stent restenosis remains the major problem limiting the efficacy of coronary stenting. Either sirolimus or paclitaxel drug-eluting stents have been demonstrated to decrease neointima proliferation resulting in a remarkable reduction of restenosis rate. However, despite the outstanding results achieved with this novel approach to restenosis, some caveats still remain. Although sirolimus markedly decreased the restenosis rate among diabetic patients in SIRIUS trial, the benefit of treatment was modest in those diabetics treated with insulin as well as with lesions longer than 15 mm located in vessels smaller than 2.5 mm. Additionally, in a recent study it was reported that the restenosis rate in high-risk lesions such as coronary bifurcations still remains a problem Data from patient populations other than those enrolled in randomized trials suggest even more caution in the evaluation of the impact of DES on restenosis in the "real world", where the operator must deal with in-stent restenosis, bifurcation lesions, chronic total occlusions, small vessels, and long lesions. The identification of some of the traditional risk factors for restenosis as important predictors for in-DES restenosis could be explained as an insufficient inhibition of tissue reaction and neointimal growth by the antiproliferative action of the specific drug or dose used. This leads to the inference that an individualized approach should be adopted by tailoring the choice and the dosing of eluting drug(s) according to the specific lesion or patient characteristics. On the other hand, although drug-eluting stents are currently considered as the most effective way to reduce in-stent restenosis, their widespread use is hampered by the high costs. Therefore, it is important to develop new methods and techniques that would result in a more effective prevention of in-stent restenosis while being available for a larger number of patients. These considerations as well as the proven efficacy of rapamycin in lowering the rate of coronary restenosis, support the rationality of the concept of on-site coating of stents in the catheterization laboratory with individualized doses of rapamycin after the clinical and the angiographic profiles of the patient scheduled to coronary stenting have been determined

Being tested
2% rapamycin-eluting YUKONdes PEARL-stent, 1% rapamycin-eluting YUKONdes PEARL-stent, YUKONdes PEARL-stent coated with placebo (ethanol)
Medical subject headings
Coronary Disease

What participants receive

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

  • 2% rapamycin-eluting YUKONdes PEARL-stentDevice

  • 1% rapamycin-eluting YUKONdes PEARL-stentDevice

  • YUKONdes PEARL-stent coated with placebo (ethanol)Device

What is being measured

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

  1. Binary angiographic restenosis at follow-up angiogram

Secondary outcomes (1)

  1. Target vessel failure (all-cause death, myocardial infarction, or revascularization of the target lesion)

Timeline

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

  1. First posted9 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Study completionFeb 2007

Why it stopped: Slow enrolement

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
Double blind
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00152308
Sponsor's protocol ID
GE IDE No. S01903
Status last verified
Sep 2005
First submitted
8 Sep 2005
Last updated
8 Oct 2020
Results posted
No

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

  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PubMed 12050336

  • Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, Staberock M, de Feyter P, Muller R, Regar E, Degertekin M, Ligthart JM, Disco C, Backx B, Russell ME. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003 Feb 4;107(4):559-64. doi: 10.1161/01.cir.0000048184.96491.8a.

    PubMed 12566366

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2% rapamycin-eluting YUKONdes PEARL-stent and 1% rapamycin-eluting YUKONdes PEARL-stent in people with Coronary Disease, run by Translumina GmbH at 10 sites in 3 countries.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Austria, Germany, Israel. 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 was stopped early (reason given: Slow enrolement). Results are not available in the source record.

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?

Binary angiographic restenosis at follow-up angiogram. 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 NCT00152308, which also lists 3 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 Oct 2020.

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