Peripheral Vascular DiseasesPhase 1/2DECODENCT00489164
Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment of Diabetic Patients With Native Coronary Artery Lesions
A Phase 1/2 study testing Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in people with Peripheral Vascular Diseases, run by Cordis US Corp. at 11 sites in 5 countries.
Trial summary
The main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Sirolimus-Eluting BX Velocity Balloon-Expandable Stent
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Aug 2002to May 2004
- Phase
- Phase 1/2
- 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;
- Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. (Undocumented or newly diagnosed diabetics must have fasting plasma glucose of >/= 126 mg/dl or a 2h post-load value in the OGTT >/=200 mg/dl, confirmed on alternate days);
- Female of childbearing potential must have a negative pregnancy test and must plan to be on accepted method of contraception for 6 months after time of enrollment;
- 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-III) OR patients with documented silent ischemia;
- Treatment of lesions in native coronary arteries requiring a maximum of three stents per patient. Multi-vessel treatment is permissible. Additional stents may be used for procedural complications such as dissections. Patients with additional lesions can be included only if the other lesions are not considered clinically significant and do not require treatment;
- Target lesion is >/=2.25 and </=3.0 in diameter (visual estimate);
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- Individual lesions are >/=10 mm to </= 32 mm in length located in a native coronary artery;
- Target lesions are de novo lesions in native coronary vessels;
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);
- 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 Institutional Review Board.
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;
- Patients admitted for treatment of diabetic ketoacidosis >/= 2 times in the past six months (Brittle Diabetics);
- Intervention of another lesion has occurred within six months prior to index procedure;
- Have an ostial target lesion;
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- Target lesion is in a saphenous venous graft.
- Target lesion is due to in-stent restenosis.
- Angiographic evidence of thrombus within target lesion;
- Calcified lesions which cannot be successfully predilated;
- Ejection fraction </=30%;
- Totally occluded vessel (TIMI 0 level);
- Impaired renal function (creatinine > 2.0 mg/dL);
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
- Pretreatment with devices other than balloon angioplasty (direct stenting is not allowed);
- Target lesion involves bifurcation including a side branch >/=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
- Previous brachytherapy of target vessel;
- Recipient of heart transplant;
- Patient with a life expectancy less than 12 months;
- Known allergies to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, stainless steel, contrast agent or sirolimus, that cannot be medically managed;
- 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;
- Treatment with Metformin (glucophage) within 48 hours of angiogram.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
St Luke's Hospital
Kansas City, Missouri, 64111
Foundation for Cardiovascular Medicine
La Jolla, California, 92037
Florida Hospital
Orlando, Florida, 32803
India4 sites
Apollo Hospital
Chennai, Tamil Nadu, 600006
Jaslok Hospital & Research Centre
Mumbai, 400 026
Batra Hospital & Research Centre
New Delhi, National Capital Territory of Delhi, 110062
Escorts Heart Institute & Research Centre
New Delhi, 110 025
About this study
Official title: A Randomized Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment of Diabetic Patients With Native Coronary Artery Lesions (DECODE)
The main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Sirolimus-Eluting BX Velocity Balloon-Expandable Stent
- Keywords
- DIABETIC PATIENTS WITH NATIVE CORONARY ARTERY LESIONS
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-Eluting BX Velocity Balloon-Expandable StentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment.
Measured: 6 months post-procedure
Secondary outcomes (9)
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 1 year post-procedure
Measured: at 30 days, 6 months and 1 year post-procedure
Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure
Measured: at 30 days, 6 months and 1 year post-procedure
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure
Measured: at 30 days, 6 months and 1 year post-procedure
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used
Measured: Throughout study
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method
Measured: Throughout study
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay
Measured: Throughout study
In-stent mean percent diameter stenosis (%DS), Binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
Measured: at post-procedure and at 6-months
In-lesion mean percent diameter stenosis (%DS), mean lumen diameter (MLD), binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
Measured: at post-procedure and at 6-months
Glycemic control as measured by HbA1C at 6 months and 1 year follow-up
Measured: at 6 months and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startAug 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maurice Buchbinder, MD, Principal investigator, Scripps Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489164
- Sponsor's protocol ID
- P02-6316, P01-6311
- Acronym
- DECODE
- Status last verified
- Nov 2008
- First submitted
- 20 Jun 2007
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan C, Zambahari R, Kaul U, Lau CP, Whitworth H, Cohen S, Buchbinder M; DECODE Investigators. A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: the DECODE study. Catheter Cardiovasc Interv. 2008 Nov 1;72(5):591-600. doi: 10.1002/ccd.21719.
PubMed 18949772
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment of Diabetic Patients With Native Coronary Artery Lesions (DECODE)
- ClinicalTrials.gov ID
- NCT00489164
- Acronym / sponsor ID
- DECODE / P02-6316, P01-6311
- Conditions
- Peripheral Vascular Diseases
- Keywords
- DIABETIC PATIENTS WITH NATIVE CORONARY ARTERY LESIONS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- May 2004 (actual)
- First posted
- 21 Jun 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 main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient must be 18 years of age;
- Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. (Undocumented or newly diagnosed diabetics must have fasting plasma glucose of >/= 126 mg/dl or a 2h post-load value in the OGTT >/=200 mg/dl, confirmed on alternate days);
- Female of childbearing potential must have a negative pregnancy test and must plan to be on accepted method of contraception for 6 months after time of enrollment;
- 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-III) OR patients with documented silent ischemia;
- Treatment of lesions in native coronary arteries requiring a maximum of three stents per patient. Multi-vessel treatment is permissible. Additional stents may be used for procedural complications such as dissections. Patients with additional lesions can be included only if the other lesions are not considered clinically significant and do not require treatment;
Key exclusion criteria (23 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;
- Patients admitted for treatment of diabetic ketoacidosis >/= 2 times in the past six months (Brittle Diabetics);
- Intervention of another lesion has occurred within six months prior to index procedure;
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 BX Velocity Balloon-Expandable Stent | Device | – |
Primary outcome
In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment.
Time frame: 6 months post-procedure
9 secondary outcomes
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year post-procedure
Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year post-procedure
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year post-procedure
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used
Time frame: Throughout study
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method
Time frame: Throughout study
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay
Time frame: Throughout study
In-stent mean percent diameter stenosis (%DS), Binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
Time frame: at post-procedure and at 6-months
In-lesion mean percent diameter stenosis (%DS), mean lumen diameter (MLD), binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
Time frame: at post-procedure and at 6-months
Glycemic control as measured by HbA1C at 6 months and 1 year follow-up
Time frame: at 6 months and 1 year follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2008.
- Results publication: PubMed 18949772Chan C, Zambahari R, Kaul U, Lau CP, Whitworth H, Cohen S, Buchbinder M; DECODE Investigators. A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: the DECODE study. Catheter Cardiovasc Interv. 2008 Nov 1;72(5):591-600. doi: 10.1002/ccd.21719.
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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.
Maurice Buchbinder, MD principal investigator
Scripps Memorial Hospital
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in people with Peripheral Vascular Diseases, run by Cordis US Corp. at 11 sites in 5 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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 11 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, India, China, Malaysia, Singapore. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. 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?
In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment. (time frame: 6 months 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 NCT00489164, which also lists 1 linked publication.
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 11 Nov 2008; AzTrials last refreshed its copy on 4 Nov 2026.