Diabetes MellitusPhase 4TITANIC-XVNCT01510509
The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
A Phase 4 study testing Titanium bare metal stent (Titan2®) and Everolimus Drug Eluting Stent (Xience-V®) in people with Diabetes Mellitus and Percutaneous Coronary Intervention, run by Hospital Universitario Infanta Cristina at 8 sites in 2 countries.
Trial summary
Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Percutaneous Coronary Intervention
- What is being tested?
- Titanium bare metal stent (Titan2®) and Everolimus Drug Eluting Stent (Xience-V®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2009to not given
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Diabetes mellitus according to the World Health Organization Report
- Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft.
- Informed Consent "signed"
- Pregnancy
- STEMI within 48 hours
Show all 19Show fewer
- Unprotected left main disease
- Restenotic lesions
- Stent diameter < 2,5 mm or > 3,5 mm
- Stent length more than 28 mm in < 3 mm vessels
- Chronic total occlusions
- Allergy to aspirin, clopidogrel, heparin or abciximab
- Active bleeding or a significant increase in bleeding risk
- Significant renal insufficiency defined as creatinine > 2 mg/dl
- Severely depressed LV function (EF≤35%)
- Cardiogenic shock
- Ischemic stroke within the last 6 months
- Contraindication for DES
- Disease with life expectancy < 12 months
Who cannot join
None listed.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain7 sites
Hospital Universitario Infanta Cristina
Badajoz, Badajoz, 06006
Hospital Juan Ramón Jiménez de Huelva
Huelva, Huelva, 21005
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Puerto Real de Cádiz
Puerto Real, Cadiz, 11510
Hospital Virgen de la Salud de Toledo
Toledo, Toledo, 45004
Hospital de Torrevieja
Torrevieja, Alicante, 03180
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Finland1 site
Heart Center, Satakunta Hospital, Pori, Finland
Satakunta, Pori, 28500
About this study
Official title: TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent.
The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention.
- Being tested
- Titanium bare metal stent (Titan2®), Everolimus Drug Eluting Stent (Xience-V®)
- Keywords
- Drug Eluting Stent, Bioactive Bare Metal Stent
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium bare metal stent (Titan2®)Device
Titan2®, Hexacath, Paris, France
Everolimus Drug Eluting Stent (Xience-V®)Device
Xience-V®, Abbott Vascular, Santa Clara, California, USA
| Study group | Role | What they receive |
|---|---|---|
| Titanium bare metal stent | Experimental | Titanium bare metal stent (Titan2®, Hexacath, Paris, France) Receives: Device: Titanium bare metal stent (Titan2®) |
| Everolimus Drug Eluting Stent | Experimental | Xience-V®, Abbott Vascular, Santa Clara, California, USA Receives: Device: Everolimus Drug Eluting Stent (Xience-V®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies.
Secondary outcomes (1)
Late luminal loss
Comparison of late luminal loss within the in-segment zone at 9 months between the two treatment strategies in the subgroup of patients with angiographic follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Cristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ramon Lopez Minguez, Hospital Universitario Infanta Cristina
- Investigators
- Jose Ramon Lopez-Minguez, MD, Principal investigator, Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510509
- Sponsor's protocol ID
- TITANIC-XV
- Acronym
- TITANIC-XV
- Status last verified
- Dec 2008
- First submitted
- 11 Jan 2012
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
- ClinicalTrials.gov ID
- NCT01510509
- Acronym / sponsor ID
- TITANIC-XV / TITANIC-XV
- Keywords
- Drug Eluting Stent, Bioactive Bare Metal Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hospital Universitario Infanta CristinaUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 16 Jan 2012 (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.
Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent.
The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium bare metal stent | Experimental | Device: Titanium bare metal stent (Titan2®)Titanium bare metal stent (Titan2®, Hexacath, Paris, France) |
| Everolimus Drug Eluting Stent | Experimental | Device: Everolimus Drug Eluting Stent (Xience-V®)Xience-V®, Abbott Vascular, Santa Clara, California, USA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age over 18 years
- Diabetes mellitus according to the World Health Organization Report
- Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft.
- Informed Consent "signed"
- Pregnancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Titanium bare metal stent (Titan2®)Titan2®, Hexacath, Paris, France | Device | Titanium bare metal stent |
| Everolimus Drug Eluting Stent (Xience-V®)Xience-V®, Abbott Vascular, Santa Clara, California, USA | Device | Everolimus Drug Eluting Stent |
Primary outcome
Major adverse cardiac events
Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies.
1 secondary outcome
Late luminal loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
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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.
Jose Ramon Lopez-Minguez, MD principal investigator
Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Titanium bare metal stent (Titan2®) and Everolimus Drug Eluting Stent (Xience-V®) in people with Diabetes Mellitus and Percutaneous Coronary Intervention, run by Hospital Universitario Infanta Cristina at 8 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 19 inclusion and 0 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 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Finland. 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?
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?
Major adverse cardiac events. 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 16 Jan 2012.