Coronary Artery DiseasePhase 3NCT00428454
Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions
A Phase 3 study testing sirolimus-eluting stent, zotarolimus-eluting stent in people with Coronary Artery Disease and Coronary Disease, run by R&D Cardiologie at 5 sites in 2 countries.
Trial summary
Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Coronary Stenosis
- What is being tested?
- sirolimus-eluting stent, zotarolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2007to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the estimated duration of the occlusion is at least 2 weeks.
- signs of ischemia related to the occluded coronary artery.
- successful recanalization of the occluded artery is achieved.
- reference diameter is > 2.5 mm.
- written informed consent obtained.
Who cannot join
- primary or rescue PCI for acute myocardial infarction
- the lesion could not be crossed.
- lesions with complex anatomy making successful stent deployment unlikely.
- the guide wire is not in the true lumen distal to the occlusion.
- Sirolimus or zotarolimus allergy
- venous or arterial bypass grafts
Show all 12Show fewer
- pregnant or nursing women.
- participation in an other trial.
- factors making long-term follow-up difficult or unlikely.
- life expectancy <1 year.
- contraindications for ASA or Clopidogrel or heparin.
- use of coumadins that could not be stopped before the procedure.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands4 sites
AMC
Amsterdam, Amsterdam, 1105AZ
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1090HM
Catharina Ziekenhuis
Eindhoven, Eindhoven, 5602ZA
St Antonius Hospital
Nieuwegein, 3435CM
About this study
Official title: A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.
Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.
Read the detailed description
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone, but restenosis rates still reach 32-55%. In 200 patients with CTO, randomized in the PRISON I study we demonstrated a restenosis rate of 22% after bare metal stent (BMS) implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients. The drug zotarolimus (ABT-578), a sirolimus analogue, is designed to inhibit the cellular process that leads to restenosis. In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36% to 7% and in-segment binary restenosis rates from 41% to 11% in favour of the sirolimus eluting stent. However, no data are available on direct comparison of the clinical efficacy, safety, and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents. The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents. It is a prospective randomized, single blinded trial comparing the relative safety, clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO.
- Conditions
- Coronary Artery Disease, Coronary Disease, Coronary Stenosis
- Being tested
- sirolimus-eluting stent, zotarolimus-eluting stent
- Keywords
- drug-eluting stent, chronic total occlusion, sirolimus-eluting stent, zotarolimus-eluting stent, QCA
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus-eluting stent, zotarolimus-eluting stentDevice
PCI in chronically occluded coronary artery
| Study group | Role | What they receive |
|---|---|---|
| Zotarolimus eluting stent | Experimental | Zotarolimus eluting stent Receives: Device: sirolimus-eluting stent, zotarolimus-eluting stent |
| Sirolimus eluting stent | Active comparator | Sirolimus eluting stent Receives: Device: sirolimus-eluting stent, zotarolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab.
Measured: 8 month
Secondary outcomes (7)
In-stent late luminal loss
Measured: 8 month
In-stent and in-segment binary restenosis rate
Measured: 8 month
In-stent and in-segment MLD
Measured: 8 month
Percentage diameter stenosis
Measured: 8 month
A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
Measured: 8 month
Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
Measured: 30 days
Target vessel failure up to 5 year of clinical follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Collaborators
- Cordis US Corp.
- Responsible party
- Principal investigator, Dr. M.J. Suttorp, R&D Cardiologie
- Investigators
- Maarten J. Suttorp, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428454
- Sponsor's protocol ID
- RDC-2006-02
- Status last verified
- Jun 2015
- First submitted
- 29 Jan 2007
- Last updated
- 4 Jun 2015
- Results posted
- No
Publications
Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22. doi: 10.1016/j.ahj.2003.11.023.
PubMed 15131557Suttorp MJ, Mast EG, Plokker HW, Kelder JC, Ernst SM, Bal ET. Primary coronary stenting after successful balloon angioplasty of chronic total occlusions: a single-center experience. Am Heart J. 1998 Feb;135(2 Pt 1):318-22. doi: 10.1016/s0002-8703(98)70099-7.
PubMed 9489982Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
PubMed 8041413Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
PubMed 8041414Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
PubMed 14523139Sirnes PA, Golf S, Myreng Y, Molstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.
PubMed 8917256Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.
PubMed 16908768Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE; ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28.
PubMed 17174180Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.
PubMed 16908773Suttorp MJ, Laarman GJ; PRISON III study investigators. A randomized comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions: rationale and design of the PRImary Stenting of Occluded Native coronary arteries III (PRISON III) study. Am Heart J. 2007 Sep;154(3):432-5. doi: 10.1016/j.ahj.2007.04.041.
PubMed 17719285
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.
- ClinicalTrials.gov ID
- NCT00428454
- Acronym / sponsor ID
- RDC-2006-02
- Conditions
- Coronary Artery Disease, Coronary Disease, Coronary Stenosis
- Keywords
- drug-eluting stent, chronic total occlusion, sirolimus-eluting stent, zotarolimus-eluting stent, QCA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Collaborators
- Cordis US Corp.
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2007 (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.
Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.
Detailed description
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone, but restenosis rates still reach 32-55%. In 200 patients with CTO, randomized in the PRISON I study we demonstrated a restenosis rate of 22% after bare metal stent (BMS) implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients. The drug zotarolimus (ABT-578), a sirolimus analogue, is designed to inhibit the cellular process that leads to restenosis. In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36% to 7% and in-segment binary restenosis rates from 41% to 11% in favour of the sirolimus eluting stent. However, no data are available on direct comparison of the clinical efficacy, safety, and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents. The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents. It is a prospective randomized, single blinded trial comparing the relative safety, clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zotarolimus eluting stent | Experimental | Device: sirolimus-eluting stent, zotarolimus-eluting stentZotarolimus eluting stent |
| Sirolimus eluting stent | Active comparator | Device: sirolimus-eluting stent, zotarolimus-eluting stentSirolimus eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the estimated duration of the occlusion is at least 2 weeks.
- signs of ischemia related to the occluded coronary artery.
- successful recanalization of the occluded artery is achieved.
- reference diameter is > 2.5 mm.
- written informed consent obtained.
Key exclusion criteria (12 listed)
- primary or rescue PCI for acute myocardial infarction
- the lesion could not be crossed.
- lesions with complex anatomy making successful stent deployment unlikely.
- the guide wire is not in the true lumen distal to the occlusion.
- Sirolimus or zotarolimus allergy
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 |
|---|---|---|
| sirolimus-eluting stent, zotarolimus-eluting stentPCI in chronically occluded coronary artery | Device | Sirolimus eluting stent, Zotarolimus eluting stent |
Primary outcome
In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab.
Time frame: 8 month
7 secondary outcomes
In-stent late luminal loss
Time frame: 8 month
In-stent and in-segment binary restenosis rate
Time frame: 8 month
In-stent and in-segment MLD
Time frame: 8 month
Percentage diameter stenosis
Time frame: 8 month
A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
Time frame: 8 month
Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
Time frame: 30 days
Target vessel failure up to 5 year of clinical follow-up.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 15131557Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22. doi: 10.1016/j.ahj.2003.11.023.
- Background: PubMed 9489982Suttorp MJ, Mast EG, Plokker HW, Kelder JC, Ernst SM, Bal ET. Primary coronary stenting after successful balloon angioplasty of chronic total occlusions: a single-center experience. Am Heart J. 1998 Feb;135(2 Pt 1):318-22. doi: 10.1016/s0002-8703(98)70099-7.
- Background: PubMed 8041413Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
- Background: PubMed 8041414Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
- Background: PubMed 14523139Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
- Background: PubMed 8917256Sirnes PA, Golf S, Myreng Y, Molstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.
- Background: PubMed 16908768Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.
- Background: PubMed 17174180Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE; ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28.
- Background: PubMed 16908773Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.
- Derived from this study: PubMed 17719285Suttorp MJ, Laarman GJ; PRISON III study investigators. A randomized comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions: rationale and design of the PRImary Stenting of Occluded Native coronary arteries III (PRISON III) study. Am Heart J. 2007 Sep;154(3):432-5. doi: 10.1016/j.ahj.2007.04.041.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Maarten J. Suttorp, MD, PhD principal investigator
St. Antonius Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sirolimus-eluting stent, zotarolimus-eluting stent in people with Coronary Artery Disease and Coronary Disease, run by R&D Cardiologie at 5 sites in 2 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 5 inclusion and 12 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 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Belgium. 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?
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-segment late luminal loss at 8 months as assessed by an independent angiographic core lab. (time frame: 8 month). 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 NCT00428454, which also lists 10 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 4 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.