Coronary Artery DiseasePhase 2/3NCT00116792
PROVIDENCE:Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With Coronary Lesions
A Phase 2/3 study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease and Diabetes Mellitus, run by Gold, Herman K., MD at 1 site in United States.
Trial summary
We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to not given
- Phase
- Phase 2/3
- 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 patients must be >18 years of age;
- Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history. (Undocumented or newly diagnosed diabetics must fulfill the American Diabetes Association Criteria-Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care 2003;26:S5-20)).
- Diagnosis of angina pectoris 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 stenting. A total of two separate lesions can be stented, located either in the same vessel (at least 10 mm or 1 cm apart) or in two separate vessels. Additional stents may be used for procedural complications such as dissections.
- 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.
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- Target lesion is ≥2.0 mm to ≤3.5mm in diameter (visual estimate);
- Individual lesions are ≤25 mm in length located in a native coronary artery;
- Target lesions are de novo lesions in native coronary vessels;
- Target lesion stenosis is ≥50% and <100% (visual estimate);
Who cannot join
- Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
- Ejection fraction ≤40%; class III-IV CHF
- Active liver disease (ALT>2.5 times upper limit of normal)
- Woman of child-bearing potential unless demonstrated 1) negative pregnancy test and 2) clear intention of an accepted method of contraception for eight months after enrollment
- Totally occluded vessel (TIMI 0 grade flow);
- Impaired renal function (creatinine ≥2.5 mg/dL);
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- Target lesion involves bifurcation including a side branch ≥2.5 mm 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 cobalt, chromium, nickel, aspirin, clopidogrel bisulfate (Plavix®) and/or ticlopidine (Ticlid®), heparin, and/or rosiglitazone (Avandia®), 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;
- Any contraindication to glycoprotein IIb/IIIa inhibitor therapy;
- Current use of any TZD, i.e. rosiglitazone (Avandia®) or pioglitazone (Actos®)
- Chronic or relapse/remitting hemolytic condition
- Unprotected left main coronary disease with >50% stenosis;
- Patients admitted for treatment of diabetic ketoacidosis >2 times in the past six months (brittle diabetics) and/or the suspicion of type I diabetes;
- Target lesion is in a saphenous venous graft or internal mammary graft;
- Target lesion is due to restenosis
- 3 vessel coronary artery disease defined as ≥70% ischemia producing lesions in 3 different epicardial coronary arteries all requiring revascularization (i.e. main left main equivalent)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: PROVIDENCE: Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With de Novo Coronary Lesions
We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2 diabetic patients. This approach would present a more effective and economical alternative to the use of drug-eluting stents to reduce stent restenosis.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- CAD, Diabetes Mellitus, Restenosis, ppar gamma, glitazone
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent and In-segment late lumen loss
Secondary outcomes (10)
In-stent mean percent diameter stenosis (%DS) and binary restenosis as measured by QCA at post-procedure and at 8 months
TLR and TVR at 30 days, and 8 months post procedure
TVF defined as cardiac death, MI, or TVR at 30 days, 8 months and l year post-procedure
Composite of Major Adverse Cardiac Events (MACE)
The association of metabolic factors and inflammatory indices including glycemia (HgbA1C), diabetic therapy other than TZDs, HSCRP, coagulation (PAI-1, FIB) and inflammatory marker levels (ADI, MPO, &MMP-9) with the risk for restenosis
Target HgbA1C≤7 for all patients enrolled
Coronary artery stenosis progression in at least one non-stented lesion
Coronary artery stenosis regression in at least one non-stented lesion
Culprit (i.e. stented artery) artery stenosis progression/regression by intravascular ultrasound (IVUS)
(There are 3 more secondary endpoints not listed here.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startMar 2004
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gold, Herman K., MD
- Collaborators
- Guidant Corporation
- Investigators
- Herman K Gold, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116792
- Sponsor's protocol ID
- 2003P-001717
- Status last verified
- May 2007
- First submitted
- 30 Jun 2005
- Last updated
- 17 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVIDENCE: Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With de Novo Coronary Lesions
- ClinicalTrials.gov ID
- NCT00116792
- Acronym / sponsor ID
- 2003P-001717
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Keywords
- CAD, Diabetes Mellitus, Restenosis, ppar gamma, glitazone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gold, Herman K., MD
- Collaborators
- Guidant Corporation
- Study start
- Mar 2004
- First posted
- 1 Jul 2005 (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.
We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2 diabetic patients. This approach would present a more effective and economical alternative to the use of drug-eluting stents to reduce stent restenosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patients must be >18 years of age;
- Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history. (Undocumented or newly diagnosed diabetics must fulfill the American Diabetes Association Criteria-Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care 2003;26:S5-20)).
- Diagnosis of angina pectoris 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 stenting. A total of two separate lesions can be stented, located either in the same vessel (at least 10 mm or 1 cm apart) or in two separate vessels. Additional stents may be used for procedural complications such as dissections.
- Patient is willing to comply with the specified follow-up evaluation;
Key exclusion criteria (21 listed)
- Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
- Ejection fraction ≤40%; class III-IV CHF
- Active liver disease (ALT>2.5 times upper limit of normal)
- Woman of child-bearing potential unless demonstrated 1) negative pregnancy test and 2) clear intention of an accepted method of contraception for eight months after enrollment
- Totally occluded vessel (TIMI 0 grade flow);
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Procedure or surgery | – |
Primary outcome
In-stent and In-segment late lumen loss
10 secondary outcomes
In-stent mean percent diameter stenosis (%DS) and binary restenosis as measured by QCA at post-procedure and at 8 months
TLR and TVR at 30 days, and 8 months post procedure
TVF defined as cardiac death, MI, or TVR at 30 days, 8 months and l year post-procedure
Composite of Major Adverse Cardiac Events (MACE)
The association of metabolic factors and inflammatory indices including glycemia (HgbA1C), diabetic therapy other than TZDs, HSCRP, coagulation (PAI-1, FIB) and inflammatory marker levels (ADI, MPO, &MMP-9) with the risk for restenosis
Target HgbA1C≤7 for all patients enrolled
Coronary artery stenosis progression in at least one non-stented lesion
Coronary artery stenosis regression in at least one non-stented lesion
Culprit (i.e. stented artery) artery stenosis progression/regression by intravascular ultrasound (IVUS)
(There are 3 more secondary endpoints not listed here.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
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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.
Herman K Gold, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease and Diabetes Mellitus, run by Gold, Herman K., MD at 1 site in United States.
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 10 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: status not confirmed, as of the sponsor's last update on 17 May 2007. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
In-stent and In-segment late lumen loss. 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 17 May 2007.