The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Phase I: Number of Participants With Dose-limiting Toxicities
Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed.
Time frame: Up to 1 week following percutaneous coronary intervention.
Number of Participants With Procedural Complications
Procedural complications include the following: 1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes; 2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia; 3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema; 4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow; 5. Clinical changes: chest pain.
Time frame: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
Time frame: Up to 6 months.
Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
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Time frame: From the day of Percutaneous Coronary Intervention to 1 Month.
Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Time frame: From the day of Percutaneous Coronary Intervention to Month 6.
Percentage of Participants With Binary Restenosis
Binary restenosis was assessed by quantitative coronary angiography and defined as \>50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.
Time frame: 6 months
Late Lumen Loss
Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography. Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up.
Time frame: Day 0 (post-procedure baseline) and 6 months.
Percentage of In-Stent Volume Obstruction at 6 Months
In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume \* 100.
Time frame: 6 months