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Coronary Artery DiseasePhase 1/2PEPCADIIINCT00473772

DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

A Phase 1/2 study testing DEBlue stent vs. Cypher stent in people with Coronary Artery Disease, run by University Hospital, Saarland at 16 sites in 8 countries.

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 aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
DEBlue stent vs. Cypher stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
643 participants
Where
16 sitesin 8 countries
Study dates
Jul 2007to Jan 2011
Phase
Phase 1/2
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 stable or unstable angina or documented ischemia due to a significant lesion in a native coronary artery
  • Patients eligible for coronary revascularization by means of PCI
  • Intention to treat one lesion with one stent
  • Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
  • Patients must be ≥ 18 years of age
  • Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 9 months follow-up
Show all 11Show fewer
  • Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
  • Patients must agree to undergo the 9 months angiographic follow-up
  • Patients must agree to undergo the 1 and 3 year clinical follow-up
  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM stent. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
  • Significant stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length

Who cannot join

  • Unprotected left main
  • In stent restenosis
  • Indication for more than one lesion to treat, even as staged procedure
  • Intended bifurcational stenting
  • Patients requiring chronic anticoagulation
  • SVG and AG
Show all 11Show fewer
  • Acute MI (STEMI, NSTEMI)
  • Cardiogenic shock
  • Chronic total occlusions
  • Pregnancy
  • Patients with stand alone balloon angioplasty, or stent deployment 6 months prior to enrolment into this study

Trial locations and contacts

16 sites in 8 countries.

16 sites in 8 countries

Germany8 sites

  • Kerckhoff-Clinic Bad Nauheim

    Bad Nauheim, 61231

  • Kardiologie, Campus Virchow-Klinikum, Charite

    Berlin, 13353

  • St. Johannes-Hospital

    Dortmund

  • Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover

  • Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

    Homburg / Saar, Saarland, 66421

  • Klinikum Ludwigshafen

    Ludwigshafen

  • University of Rostock

    Rostock

Other trials in Germany

Belgium2 sites

  • Cardiovascular Center OLV Hospital Aalst

    Aalst

  • Ziekenhuis Oost-Limburg

    Genk

Other trials in Belgium

Czechia1 site

  • Institute for Clinical and Experimental Medicine

    Prague

Other trials in Czechia

France1 site

  • Clinique Saint Martin

    Caen

Other trials in France

Netherlands1 site

  • Rihnstate Hospital

    Arnhem

Other trials in Netherlands

Spain1 site

  • Hospital Universitari Germans Trias I Pujol

    Badalona

Other trials in Spain

Sweden1 site

  • Universitetssjukhuset Lund

    Lund

Other trials in Sweden

United Kingdom1 site

  • Northern General Hospital

    Sheffield

Other trials in United Kingdom

About this study

Official title: Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease

The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.

Read the detailed description

The incidence of in-stent restenosis after percutaneous coronary intervention varies between 5 and 35% after bare metal stenting and is as high as 19% after the implantation of a drug-eluting stent in patients at moderate risk. Restenosis due to neointimal hyperplasia is a slow process, suggesting that therapeutic local drug administration would need to be prolonged to be beneficial. Stent-based local drug delivery provides sustained drug release using special release technologies like polymer coating. However, cell culture experiments indicate that even brief contact between vascular smooth muscle cells and lipophilic taxane compounds can inhibit vascular smooth muscle cell proliferation for a long period. In experiments in swine, intracoronary delivery of paclitaxel by contrast media or by a drug-coated balloon catheter was found to result in vascular tissue concentrations capable of producing antiproliferative effects, thus leading to a significant reduction in neointimal proliferation. In these animal studies, the most pronounced reduction of neointimal formation was seen with paclitaxel-coated balloon catheters.

Being tested
DEBlue stent vs. Cypher stent
Keywords
cobalt chromium stent, paclitaxel coated balloon catheter, DEBlue, drug eluting balloon
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • DEBlue stent vs. Cypher stentDevice

    DES vs. DEB with BMS

Study groups in NCT00473772
Study groupRoleWhat they receive
Cypher StentActive comparatorNot described
Receives: Device: DEBlue stent vs. Cypher stent
DEBlue StentExperimentalNot described
Receives: Device: DEBlue stent vs. Cypher stent

What is being measured

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

  1. late lumen loss

    Measured: 9 months

Secondary outcomes (4)

  1. MACE

    Measured: 9 months

  2. MACE

    Measured: 3 years

  3. MACE

    Measured: 30 days

  4. Binary restenosis rate

    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 posted15 May 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionOct 2008
  4. Study completionJan 2011

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473772
Sponsor's protocol ID
BBM-VS-54
Acronym
PEPCADIII
Status last verified
May 2014
First submitted
14 May 2007
Last updated
6 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.

    PubMed 17435062

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

    PubMed 17101615

  • Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.

    PubMed 16864669

  • Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

    PubMed 15302790

  • Speck U, Scheller B, Abramjuk C, Bernhardt U. Drug delivery by angiographic contrast media: inhibition of restenosis. Acad Radiol. 2005 May;12 Suppl 1:S14-7. doi: 10.1016/j.acra.2005.02.017. No abstract available.

    PubMed 16106539

  • Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.

    PubMed 15076010

  • Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.

    PubMed 14563585

  • Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.

    PubMed 12909076

  • Scheller B, Speck U, Schmitt A, Clauss W, Sovak M, Bohm M, Stoll HP. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Invest Radiol. 2002 Jan;37(1):29-34. doi: 10.1097/00004424-200201000-00006.

    PubMed 11753151

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DEBlue stent vs. Cypher stent in people with Coronary Artery Disease, run by University Hospital, Saarland at 16 sites in 8 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 11 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, Belgium, Czechia, France, Netherlands and 3 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

late lumen loss (time frame: 9 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 NCT00473772, which also lists 9 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 6 May 2014.

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