Coronary Artery DiseaseNCT00961311
Sprinter Legend Balloon Catheter
A study testing Percutaneous Coronary Intervention and Sprinter Legend 1.25mm Balloon Catheter in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.
Trial summary
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon. 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?
- Percutaneous Coronary Intervention and Sprinter Legend 1.25mm Balloon Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is greater than18 years of age and able to give informed consent.
- Patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (PCI).
- The patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study.
- Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
- Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site.
- Patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment.
Who cannot join
- A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- Evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (CK-MB) or troponin elevated above the Institution's upper limit of normal).
- During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc.
- History of stroke or transient ischemic attack (TIA) within the prior 6 months.
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Acute Safety and Efficacy of the Medtronic Sprinter Legend 1.25mm Balloon Dilation Catheter Utilized for Enlarging Coronary Luminal Diameters During PCI Procedures
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
Read the detailed description
The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention, Sprinter Legend 1.25mm Balloon Catheter
- Keywords
- Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia
- Medical subject headings
- Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
Sprinter Legend 1.25mm Balloon CatheterDevice
Balloon Angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Trial Arm | Experimental | All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment. Receives: Procedure: Percutaneous Coronary Intervention; Device: Sprinter Legend 1.25mm Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.
Measured: 1-3 days
Secondary outcomes (3)
Major Adverse Cardic Events (MACE)
Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Measured: 1-3 days
Vessel Perforation (Clinical)
Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.
Measured: 1-3 days
Device Success
Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Scripps Green Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961311
- Sponsor's protocol ID
- IP-111
- Status last verified
- Oct 2011
- First submitted
- 14 Jul 2009
- Last updated
- 26 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4.
PubMed 21351225
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Safety and Efficacy of the Medtronic Sprinter Legend 1.25mm Balloon Dilation Catheter Utilized for Enlarging Coronary Luminal Diameters During PCI Procedures
- ClinicalTrials.gov ID
- NCT00961311
- Acronym / sponsor ID
- IP-111
- Conditions
- Coronary Artery Disease
- Keywords
- Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 14 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
Detailed description
The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial Arm | Experimental | Procedure: Percutaneous Coronary Intervention, Device: Sprinter Legend 1.25mm Balloon CatheterAll patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is greater than18 years of age and able to give informed consent.
- Patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (PCI).
- The patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study.
- Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
- Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site.
Key exclusion criteria (7 listed)
- A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- Evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (CK-MB) or troponin elevated above the Institution's upper limit of normal).
- During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc.
- History of stroke or transient ischemic attack (TIA) within the prior 6 months.
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 InterventionBalloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon. | Procedure or surgery | Trial Arm |
| Sprinter Legend 1.25mm Balloon CatheterBalloon Angioplasty | Device | Trial Arm |
Primary outcome
Procedural Success
Time frame: 1-3 days
Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.
3 secondary outcomes
Major Adverse Cardic Events (MACE)
Time frame: 1-3 days
Vessel Perforation (Clinical)
Time frame: 1-3 days
Device Success
Time frame: 1-3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21351225Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4.
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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.
David Kandzari, MD principal investigator
Scripps Green Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention and Sprinter Legend 1.25mm Balloon Catheter in people with Coronary Artery Disease, run by Medtronic Vascular 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 6 inclusion and 7 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 26 Oct 2011. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedural Success (time frame: 1-3 days). 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 NCT00961311, 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 26 Oct 2011.