Stable Coronary Artery DiseaseDESERTNCT01243099
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions
An observational study of Stable Coronary Artery Disease and Silent Myocardial Ischemia, run by S.M. Misericordia Hospital at 1 site in Italy.
Trial summary
The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stable Coronary Artery Disease, Silent Myocardial Ischemia, In-stent(BMS)Restenosis
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Jul 2013
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paziente affected by either stable coronary artery disease or silent myocardial ischemia
Who may be able to join
- Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:
- Group A: single BMS restenosis (> 50% of luminal diameter)
- Group B: single de-novo lesion (> 50% of luminal diameter)
Who cannot join
- contraindications to dual antiplatelet therapy
- acute myocardial infarction within the previous 48 hours
- significant left main coronary artery disease
- reference vessel diameter < 2.5 mm,
- hemodynamic instability
- chronic kidney disease with serum creatinine > 2 mg/dl
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- pregnancy
- allergy to contrast agent, everolimus, aspirin, clopidogrel
- life expectancy < 24 months
- patients with possible low adherence to medical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study
The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-stent (BMS) restenosis | Not described | |
| De-novo coronary lesion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.
Measured: Measured will be assessed six-month after coronary angioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.M. Misericordia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Picchi, S.M. Misericordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243099
- Sponsor's protocol ID
- DSR-01
- Acronym
- DESERT
- Status last verified
- Jul 2013
- First submitted
- 15 Nov 2010
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study
- ClinicalTrials.gov ID
- NCT01243099
- Acronym / sponsor ID
- DESERT / DSR-01
- Conditions
- Stable Coronary Artery Disease, Silent Myocardial Ischemia, In-stent(BMS)Restenosis, De-novo, Atherosclerotic, Coronary Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- S.M. Misericordia HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Nov 2010 (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 hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-stent (BMS) restenosis | – | – |
| De-novo coronary lesion | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paziente affected by either stable coronary artery disease or silent myocardial ischemia
Key inclusion criteria (3 listed)
- Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:
- Group A: single BMS restenosis (> 50% of luminal diameter)
- Group B: single de-novo lesion (> 50% of luminal diameter)
Key exclusion criteria (10 listed)
- contraindications to dual antiplatelet therapy
- acute myocardial infarction within the previous 48 hours
- significant left main coronary artery disease
- reference vessel diameter < 2.5 mm,
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.
Time frame: Measured will be assessed six-month after coronary angioplasty
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 23 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Coronary Artery Disease and Silent Myocardial Ischemia, run by S.M. Misericordia Hospital at 1 site in Italy.
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 10 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 23 Jul 2013. 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 Italy. 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.
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?
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up. (time frame: Measured will be assessed six-month after coronary angioplasty). 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 2013.