Coronary Artery DiseasePhase 4NCT00916695
Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques
A Phase 4 study testing Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A. in people with Coronary Artery Disease, run by Spanish Society of Cardiology at 2 sites in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch). 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?
- Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2009to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old.
- True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.
Who cannot join
- Significant left main stenosis.
- ST elevation myocardial infarction < 48 h.
- Thrombus burden target lesion.
- Ejection Fraction < 30%.
- Severe Renal Insufficiency (creatinine > 3 mg/dl).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41007
Rafael J Ruiz-Salmeron, PhD, +34955693440, rjruizsalmeron@yahoo.es
- Not yet recruiting
University Hospital Virgen Macarena
Seville, Seville, 41007
Rafael j Ruiz-Salmeron, PhD, 0034955693449, rjruizsalmeron@yahoo.es
Rafael J Ruiz-Salmeron, Phd
About this study
Official title: Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent
The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).
- Conditions
- Coronary Artery Disease
- Being tested
- Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.
- Keywords
- Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions
- 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.
Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.Device
Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique.
Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique.
| Study group | Role | What they receive |
|---|---|---|
| Complex PCI strategy for bifurcation coronary lesions | Active comparator | Stenting main vessel and T-stenting for the side branch Receives: Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A. |
| Simple PCI strategies for bifurcation coronary lesions | Active comparator | Stenting main vessel, with provisional stenting for the side branch. Receives: Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups
Measured: 9 months
Secondary outcomes (1)
Combined rate of events (cardiac death, myocardial infarction and TLR)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Investigators
- Federico Gimeno, MD, Principal investigator, Hospital Clinico Universitario ValladolidBruno Garcia, MD, Principal investigator, Hospital Valle de Hebron. BarcelonaRamiro Trillo, MD, Principal investigator, Hospital Clínico SantiagoJose Moreu, MD, Principal investigator, Hospital Virgen de la SaludJavier Goicolea, MD, Principal investigator, Hospital Puerta de Hierro, MadridRaul Moreno, MD, Principal investigator, Hospital Universitario La PazJose F Diaz, MD, Principal investigator, Hospital Juan Ramon Jimenez. HuelvaJose M Hernandez, MD, Principal investigator, Hospital Clinico de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916695
- Sponsor's protocol ID
- XV02RS
- Other IDs
- XV02RS
- Status last verified
- Jul 2009
- First submitted
- 1 Jun 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent
- ClinicalTrials.gov ID
- NCT00916695
- Acronym / sponsor ID
- XV02RS
- Conditions
- Coronary Artery Disease
- Keywords
- Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 9 Jun 2009 (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.
The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex PCI strategy for bifurcation coronary lesions | Active comparator | Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.Stenting main vessel and T-stenting for the side branch |
| Simple PCI strategies for bifurcation coronary lesions | Active comparator | Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.Stenting main vessel, with provisional stenting for the side branch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old.
- True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.
Key exclusion criteria (5 listed)
- Significant left main stenosis.
- ST elevation myocardial infarction < 48 h.
- Thrombus burden target lesion.
- Ejection Fraction < 30%.
- Severe Renal Insufficiency (creatinine > 3 mg/dl).
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 |
|---|---|---|
| Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique. Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique. | Device | Complex PCI strategy for bifurcation coronary lesions, Simple PCI strategies for bifurcation coronary lesions |
Primary outcome
Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups
Time frame: 9 months
1 secondary outcome
Combined rate of events (cardiac death, myocardial infarction and TLR)
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
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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.
Federico Gimeno, MD principal investigator
Hospital Clinico Universitario Valladolid
Bruno Garcia, MD principal investigator
Hospital Valle de Hebron. Barcelona
Ramiro Trillo, MD principal investigator
Hospital Clínico Santiago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A. in people with Coronary Artery Disease, run by Spanish Society of Cardiology at 2 sites in Spain.
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 2 inclusion and 5 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 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael J Ruiz-Salmeron, PhD (0034955693440, rjruizsalmeron@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups (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 23 Jul 2009.