Stenosis in Saphenous Vein Graft, Drug Eluting StentPhase 3NCT00766129
Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts
A Phase 3 study testing Taxus stent implantation and Luc-Chopin stent in people with Stenosis in Saphenous Vein Graft, Drug Eluting Stent, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stenosis in Saphenous Vein Graft, Drug Eluting Stent
- What is being tested?
- Taxus stent implantation and Luc-Chopin stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2008to Dec 2011
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
- Stable coronary artery disease or non ST segment elevation acute coronary syndrome
- Reference segment diameter in range of 2.5-4.5mm
Who cannot join
- Cardiogenic shock
- Contraindications to prolonged dual antiplatelet therapy
- Female of child birth potential unless on effective contraception
- Other medical condition that may limit survival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.
Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.
- Being tested
- Taxus stent implantation, Luc-Chopin stent
- Keywords
- saphenous vein graft, TAXUS stent, Chopin stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxus stent implantationDevice
Patients will be treated with implantation of Taxus stent
Luc-Chopin stentDevice
Patients will be treated will implantation of Luc-Chopin stent
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | Implantation of Taxus stent into saphenous vein graft Receives: Device: Taxus stent implantation |
| C | Experimental | Implantation of Luc-Chopin stent into saphenous vein graft Receives: Device: Luc-Chopin stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neointima hyperplasia volume by Intravascular Ultrasound
Measured: 9 months
Secondary outcomes (5)
All cause mortality
Measured: 5 years
Cardiovascular mortality
Measured: 5 years
Stent thrombosis
Measured: 5 years
Target lesion revascularization
Measured: 5 years
Angiographic late loss
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis in Saphenous Vein Graft, Drug Eluting StentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Adam R Witkowski, MD,PhD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766129
- Sponsor's protocol ID
- N403 2786 33
- Status last verified
- Jul 2011
- First submitted
- 2 Oct 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.
- ClinicalTrials.gov ID
- NCT00766129
- Acronym / sponsor ID
- N403 2786 33
- Keywords
- saphenous vein graft, TAXUS stent, Chopin stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Device: Taxus stent implantationImplantation of Taxus stent into saphenous vein graft |
| C | Experimental | Device: Luc-Chopin stentImplantation of Luc-Chopin stent into saphenous vein graft |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
- Stable coronary artery disease or non ST segment elevation acute coronary syndrome
- Reference segment diameter in range of 2.5-4.5mm
Key exclusion criteria (4 listed)
- Cardiogenic shock
- Contraindications to prolonged dual antiplatelet therapy
- Female of child birth potential unless on effective contraception
- Other medical condition that may limit survival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taxus stent implantationPatients will be treated with implantation of Taxus stent | Device | T |
| Luc-Chopin stentPatients will be treated will implantation of Luc-Chopin stent | Device | C |
Primary outcome
Neointima hyperplasia volume by Intravascular Ultrasound
Time frame: 9 months
5 secondary outcomes
All cause mortality
Time frame: 5 years
Cardiovascular mortality
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
Target lesion revascularization
Time frame: 5 years
Angiographic late loss
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam R Witkowski, MD,PhD principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxus stent implantation and Luc-Chopin stent in people with Stenosis in Saphenous Vein Graft, Drug Eluting Stent, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 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?
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?
Neointima hyperplasia volume by Intravascular Ultrasound (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2011.