Coronary Artery DiseasePhase 4DESSERTNCT00497172

Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial

A Phase 4 study testing CYPHER Sirolimus-eluting stent and Bx SONIC bare metal stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent. 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?: CYPHER Sirolimus-eluting stent and Bx SONIC bare metal stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteItaly
Study dates: Jan 2004to Apr 2009
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

The patient must be ≥ 18 years of age;
Female of childbearing potential must have a negative pregnancy test within 7days of enrollment and utilize reliable birth control for eight months after enrollment;
Patients with IDDM (Type I) treated for at least 3 months with documented HbA1c, or NIDDM (Type II) treated with oral antidiabetics for at least 3 months;
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia OR patient with previous (>24 hours) myocardial infarction with documented residual ischemia and/or viable myocardium;
Single or double stent treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multi-vessel disease can be included only if a maximum of two vessels require treatment with a maximum of three lesions in total, no more than two lesions per vessels. The two lesions in a single vessel must be >10 mm apart (visual estimate) and must be treated with the assigned stent.
Target vessel diameter at the lesion site is ≥ 2.50mm and ≤ 3.5mm in diameter (visual estimate);

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Target lesion is ≥ 13mm and ≤ 25mm in length (visual estimate);
Target lesion stenosis is >50% and <100% (visual estimate);
At least TIMI II coronary flow;
Acceptable candidate for coronary artery bypass surgery (CABG);
Patient is willing to comply with the specified follow-up evaluation;
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee;
Patient can be pretreated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI, and GPIIb IIIa inhibitors (Tirofiban or Abciximab)

Who cannot join

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
Unprotected left main coronary disease with ≥50% stenosis;
Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Have a target lesion in an arterial or venous by-pass graft;
Calcified lesion which cannot be successfully predilated;
Documented left ventricular ejection fraction ≤ 30%;

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TIMI 0-I coronary flow ;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Pretreatment with devices other than balloon angioplasty;
Target lesion has excessive tortuousity or angulation (>45°) which makes it unsuitable for stent delivery and deployment;
Target lesion involves bifurcation including a diseased side branch ≥2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;
Prior stent within 5mm of target lesion;
Direct Stenting;
Recipient of heart transplant;
Patient with a life expectancy less than 12 months;
Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix), heparin and GPIIb IIIa inhibitors (Tirofiban or Abciximab) stainless steel, contrast agent (that cannot be managed medically), or sirolimus;
Recent (6 months) cerebrovascular accidents or intracranial hemorrhage;
Any significant medical condition which in the investigator.s opinion may interfere with the patient.s optimal participation in the study;
Currently participating in an investigational drug or another device study;
Intervention of another lesion has occurred within 6 months before the index procedure;
In the investigator.s opinion, the lesion is not suitable for stenting.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda USL Ravenna - Ospedale santa Maria delle Croci
Ravenna, 48100

Other trials in Italy

About this study

Official title: An Italian Multicenter, Randomized, Single Blind Study of the Sirolimus Eluting Stent in the Treatment Of Diabetic Patients With De Novo Coronary Artery Lesions

The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).

Read the detailed description

This is a multicenter (11 centers), prospective, randomized single blind study. This study has a 2-arm design assessing the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version to the bare metal Bx SONICTM stent. A total of 250 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to the Sirolimus-eluting stent or the bare metal Bx SONIC stent. The investigator cannot be blind because the outer appearance of the system for the implant of the Sirolimus-eluting stent differs from that of the bare metal stent and will therefore immediately be recognized by the surgeon. However the patient will not know which stent will be implanted. Patients will be followed at 30 days, 9 and 12 months post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 1 year follow-up period will be collected and analyzed.

Conditions: Coronary Artery Disease
Being tested: CYPHER Sirolimus-eluting stent, Bx SONIC bare metal stent
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.

CYPHER Sirolimus-eluting stentDevice
drug-eluting stent
Bx SONIC bare metal stentDevice
bare-metal stent

Study groups in NCT00497172
Study group	Role	What they receive
1	Experimental	drug-eluting stent Receives: Device: CYPHER Sirolimus-eluting stent
2	Active comparator	bare-metal stent Receives: Device: Bx SONIC bare metal stent

What is being measured

The primary outcome is the main question the study is designed to answer.

in-stent LL
Measured: 8-month post-procedure

Secondary outcomes (3)

MACE
Measured: 1, 9, and 12 Months
Target vessel failure
Measured: 12 months
Target lesion or target vessel revascularization
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Apr 2009

First posted6 Jul 2007 (estimated)
Study startJan 2004
Primary completionMar 2006
Study completionApr 2009

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: Single blind
Who is masked: Participant
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00497172
Sponsor's protocol ID: CRDIT 00-02/02
Acronym: DESSERT
Status last verified: Feb 2010
First submitted: 4 Jul 2007
Last updated: 4 Feb 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Italian Multicenter, Randomized, Single Blind Study of the Sirolimus Eluting Stent in the Treatment Of Diabetic Patients With De Novo Coronary Artery Lesions
ClinicalTrials.gov ID: NCT00497172
Acronym / sponsor ID: DESSERT / CRDIT 00-02/02
Conditions: Coronary Artery Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Cordis US Corp.Industry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Mar 2006 (actual)
Study completion: Apr 2009 (actual)
First posted: 6 Jul 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.

The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: CYPHER Sirolimus-eluting stentdrug-eluting stent
2	Active comparator	Device: Bx SONIC bare metal stentbare-metal stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

The patient must be ≥ 18 years of age;
Female of childbearing potential must have a negative pregnancy test within 7days of enrollment and utilize reliable birth control for eight months after enrollment;
Patients with IDDM (Type I) treated for at least 3 months with documented HbA1c, or NIDDM (Type II) treated with oral antidiabetics for at least 3 months;
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia OR patient with previous (>24 hours) myocardial infarction with documented residual ischemia and/or viable myocardium;
Single or double stent treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multi-vessel disease can be included only if a maximum of two vessels require treatment with a maximum of three lesions in total, no more than two lesions per vessels. The two lesions in a single vessel must be >10 mm apart (visual estimate) and must be treated with the assigned stent.

Key exclusion criteria (21 listed)

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
Unprotected left main coronary disease with ≥50% stenosis;
Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Have a target lesion in an arterial or venous by-pass graft;
Calcified lesion which cannot be successfully predilated;

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
CYPHER Sirolimus-eluting stentdrug-eluting stent	Device	1
Bx SONIC bare metal stentbare-metal stent	Device	2

Primary outcome

in-stent LL
Time frame: 8-month post-procedure

3 secondary outcomes

MACE
Time frame: 1, 9, and 12 Months
Target vessel failure
Time frame: 12 months
Target lesion or target vessel revascularization
Time frame: 12 months

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 Feb 2010.

Related trials for Coronary Artery Disease

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Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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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.

A. Maresta, MD principal investigator

Azienda USL Ravenna

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CYPHER Sirolimus-eluting stent and Bx SONIC bare metal stent in people with Coronary Artery Disease, run by Cordis US Corp. 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 13 inclusion and 21 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 Feb 2010. 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.

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?

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-stent LL (time frame: 8-month post-procedure). 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 NCT00497172.

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 Feb 2010.