coronary heartdisease In-stent restenosis
Conditions
Interventions
Percutaneous access must comply with existing hospital standard procedures.
Once access is obtained, heparin, or other antiplatelet therapy, should be
administered to keep ACT > 250 seconds (see Con
Sponsors
Caliber Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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%. 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
Exclusion criteria
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 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 2 mm diameter.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints Primary Safety * Target Lesion Failure (TLF) * composite of cardiac death, target vessel Myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) up to 30 days post index procedure. * A revascularization (TLR or TVR) is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis *50% (core lab QCA assessment) and abnormal results from a fractional flow reserve (FFR) test. * MI is indicated when in patients with normal baseline CK-MB, the peak CK-MB measured within > 48 hours of the procedure rises to > 10x the local laboratory ULN, or to > 5x ULN with new pathologic Q-waves in 2 contiguous leads or new persistent LBBB. Primary Late Lumen Loss (LLL) at 6 months follow-up assessed by Quantitative Coronary Angiography (QCA) and adjudicated by an independent Angiographic Core Lab. (Clinical work-up must be completed prior to any catheterization procedure.) LLL = MLDp * MLD6 months, where MLD is minimal lumen diameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints * Percent in-treatment volume obstruction at 6 months follow-up as measured by IVUS core lab. * Device Success: The Investigational Device was delivered, dilated, delivered the Sirolimus therapeutic dose and was retrieved from the target lesion. * Procedural Success: Defined as *Device Success* without the occurrence of Major adverse cardiac events [MACE] per CEC adjudication (death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically indicated target vessel revascularization (TVR), clinically driven target lesion revascularization (TLR), and target vessel failure (TVF)) during the index hospitalization. * MACE rates at the following time periods: in hospital, 30 days, 6-months, 1, 2, and3 year follow-up. * Binary in-stent restenosis rate at 6 months follow-up: o Binary restenosis via QCA; o Follow up % diameter stenosis via QCA; | — |
Countries
Netherlands
Outcome results
None listed