NL-OMON41496
Completed
Not Applicable
Sirolimus Eluting Angioplasty Balloon for In-Stent REstenosis (SABRE) Trial - SABRE
Caliber Therapeutics, Inc.0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- coronary heartdisease
- Sponsor
- Caliber Therapeutics, Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •1\.Age \> 18 years
- •2\.Patient is willing to provide informed written consent and comply with follow\-up visits and testing schedule.
- •3\.Patients eligible and indicated for in\-stent PCI with documented evidence of ischemia by invasive or non\-invasive diagnostic method.
- •4\.Patients who are eligible for coronary revascularization (angioplasty and/or CABG)
- •5\.Female patients of child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception.
- •6\.Previous history of native coronary bare metal stenting \* 1 month or drug eluting stenting \* 3 months.;Angiographic Inclusion Criteria
- •7\.Target vessel with Reference Vessel Diameter (RVD) from 2\.5 to 3\.5 mm by coronary angiography.
- •8\.Target lesion is in a native coronary artery with previous bare metal stent or drug eluting stent. Target lesion with overlapping stents is acceptable if lesion is within stent. (Balloon should be sized so that it does not extend more than 2 mm from the edge of the stent.)
- •9\.Inclusion permitted following successful pre\-dilatation of target ISR lesion with remaining residual stenosis of \* 40%.
Exclusion Criteria
- •Exclusion Criteria
- •1\.Patient enrolled in another study with any investigational drug or device, who have not reached primary endpoint.
- •2\.Patients scheduled for a major surgical intervention within 7 months of enrollment of the study.
- •3\.Patients with recent (\* 72 hours) unstable coronary syndromes (e.g. ACS or STEMI \* ST elevated myocardial infarction (MI)). If patient has had NSTEMI prior to 72 hrs. and enzyme level is decreasing within 72 hrs. (at least 2 measurements showing decreasing trend) and patient meets AHA risk guidelines for PCI procedure (low risk) then patient is eligible.
- •4\.Patients with a contraindication to an emergency coronary bypass surgery.
- •5\.Any individual who refuses a blood transfusion if needed.
- •6\.Patients with serum creatinine \> 2\.0 mg/dL or \> 177umol/L.
- •7\.Patients with platelet count \< 50,000 cells/mm³.
- •8\.Patients who had a cerebral stroke \< 6 months prior to the index procedure.
- •9\.Documented LVEF (Ejection Fraction) \< 30% tested within 4 weeks prior to index procedure.
Outcomes
Primary Outcomes
Not specified
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