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Coronary Artery DiseasePhase 2/3NCT00732953

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

A Phase 2/3 study testing Genous stent implantation with paclitaxel-eluting balloon dilation and Genous stent implantation in people with Coronary Artery Disease, run by University of Ulm 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

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. 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?
Genous stent implantation with paclitaxel-eluting balloon dilation and Genous stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesGermany
Study dates
Feb 2009to Feb 2014
Phase
Phase 2/3
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 >18 years old
  • lesion in native coronary artery
  • de-novo stenosis
  • indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
  • range of reference diameter 2.5 to 4.0mm

Who cannot join

  • lesion in saphenous vein graft
  • chronic total occlusion
  • bifurcation lesion requiring stenting of main and side branch
  • left main stenosis
  • restenosis
  • in-Stent restenosis
  • contraindication for dual antiplatelet therapy for the following 6 months
  • coronary aneurysm in target vessel

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Klinikum Coburg

    Coburg, 96450

  • University of Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78011

Other trials in Germany

About this study

Official title: Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.

Being tested
Genous stent implantation with paclitaxel-eluting balloon dilation, Genous stent implantation
Keywords
patients with coronary artery disease, percutaneous coronary intervention, stent implantation, paclitaxel eluting balloon, angiographic follow-up, clinical follow-up
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.

  • Genous stent implantation with paclitaxel-eluting balloon dilationDevice

    Genous stent implantation with paclitaxel-eluting balloon therapy

  • Genous stent implantationDevice

    Genous stent implantation

Study groups in NCT00732953
Study groupRoleWhat they receive
1Active comparatorGenous stent implantation with paclitaxel-eluting balloon therapy
Receives: Device: Genous stent implantation with paclitaxel-eluting balloon dilation
2Active comparatorGenous stent implantation
Receives: Device: Genous stent implantation

What is being measured

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

  1. Late loss

    Measured: 6 months

Secondary outcomes (7)

  1. Diameter stenosis

    Measured: 6 months

  2. Binary restenosis rate

    Measured: 6 month

  3. Late loss index

    Measured: 6 months

  4. Target lesion revascularization

    Measured: 2, 6, 12, 24, 36, 48, 60 months

  5. Target vessel revascularization

    Measured: 2, 6, 12, 24, 36, 48, 60 months

  6. Major adverse cardiac events

    Measured: 2, 6, 12, 24, 36, 48, 60 months

  7. Stent thrombosis

    Measured: 2, 6, 12, 24, 36, 48, 60 months

Timeline

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

  1. First posted12 Aug 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2010
  4. Study completionFeb 2014

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00732953
Sponsor's protocol ID
UULM-JW-GP
Status last verified
Jun 2014
First submitted
7 Aug 2008
Last updated
10 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H. Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011 Aug;97(16):1338-42. doi: 10.1136/hrt.2011.226563. Epub 2011 May 26.

    PubMed 21617163

  • Seeger J, Markovic S, Birkemeyer R, Rittger H, Jung W, Brachmann J, Rottbauer W, Wohrle J. Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease: final 5-year results of a randomized prospective multicenter trial. Coron Artery Dis. 2016 Mar;27(2):84-8. doi: 10.1097/MCA.0000000000000314.

    PubMed 26479969

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Genous stent implantation with paclitaxel-eluting balloon dilation and Genous stent implantation in people with Coronary Artery Disease, run by University of Ulm 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 5 inclusion and 8 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 10 Jun 2014. 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 combined phase mean?

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

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 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 NCT00732953, 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 10 Jun 2014.

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