Coronary Restenosis
Conditions
Keywords
Coronary Restenosis, restenosis, paclitaxel-coated balloon, drug-eluting stent, drug-coated balloon, coronary angiography
Brief summary
Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)
Detailed description
The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.
Interventions
DEVICEPCB
PCB with Citrate-based excipient
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels. 2. Written, informed consent by the patient for participation in the study. 3. In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion criteria
1. Age \< 18 years 2. Cardiogenic shock 3. Acute ST-elevation myocardial infarction within 48 hours from symptom onset. 4. Target lesion located in the left main trunk or bypass graft. 5. Target lesion located in small vessel (vessel size \< 2.0 mm) 6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. 7. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) 8. Contraindications to antiplatelet therapy, paclitaxel 9. Pregnancy (present, suspected or planned) or positive pregnancy test. 10. Previous enrollment in this trial. 11. Patient's inability to fully comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment percent diameter stenosis (%DS) | at 6-8 months |
Secondary
| Measure | Time frame |
|---|---|
| In-segment minimal lumen diameter and binary restenosis | at 6-8 months |
| Composite of death or myocardial infarction | at 12 months |
| Target lesion revascularization and thrombosis | at 12 months |
Countries
Germany
Outcome results
None listed