Sirolimus Eluting Angioplasty Balloon for In-Stent REstenosis (SABRE) Trial

Completed

Conditions: coronary heartdisease
In-stent restenosis
10011082

Registration Number: NL-OMON41496

Lead Sponsor: Caliber Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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%.
o No SAEs
o No flow limiting dissection requiring additional procedures or implantation of a stent
o Lesion continues to meet inclusion criteria of length and diameter
o No uncontrollable spasm
10.Target lesion length < 21mm by coronary angiograph (note: Virtue should extend at least 2mm beyond pre-dilatation balloon length to avoid geographical miss).
11.Guide wire is able to cross lesion and be placed in distal vessel prior to enrollment.
12.Inclusion permitted after successful treatment of 1 non-study, low risk lesion in a single non-study vessel.

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.
10.Patients with any known allergy, hypersensitivity or intolerance to anti-platelet therapy (for example ASA, clopidogrel or ticlopidine) and sirolimus.
11.Any known allergy to contrast medium that cannot be pre-treated.
12.Women who are pregnant or breastfeeding.;Angiographic Exclusion Criteria
13.More than 1 target lesion within the target vessel.
14.Presence of any non-target lesion within the target vessel.
15.Failure to successfully treat the non-target vessel (non-target vessel must be treated prior to the target vessel)
16.Aorto-ostial lesion (Left Main or Ostial Right Coronary Artery).
17.Target lesion distance from the ostium of LAD/LCX is < 5 mm.
18.Target lesion is located in either a venous or arterial graft.
19.Lesions at edge of stent requiring dilatation > 2 mm beyond stent.
20.Angiographic evidence of thrombus at the target site.
21.Acute total occlusions of non-target lesion or > 40% stenosis of target lesion following pre-dilatation.
22.Lesion requiring additional implant or results in flow limiting dissection following pre-dilatation.
23.Bifurcation lesions (lesions < 5 mm from a side branch vessel with > 2 mm diameter.)