Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
Conditions
Keywords
In-stent Restenosis, Drug Eluting Stent, Paclitaxel Coated Balloon, Scoring Balloon, Cutting Balloon, Angiographic follow-up, Optical coherence tomography (OCT)
Brief summary
The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within limus-eluting stents (LES)
Detailed description
The optimal treatment of in-BMS-restenosis seems to be implantation of a DES which is supported by a large body of evidence. Nevertheless, several recent published studies have shown a substantial reduction in late lumen loss and angiographic restenosis using paclitaxel-coated balloons (PCB) for restenotic lesions. Given the increased world-wide use of DES and the use of DES in increasingly complex coronary disease patterns, the number of patients presenting with restenosis after DES implantation will further increase in the coming decade. Data regarding the optimal treatment of in-DES-restenosis are very limited: Implanting a new DES for in-DES-restenosis has been reported to associate with repeat restenosis rates as high as 20%. In addition, an increased risk of stent thrombosis has been associated with complex stenting and with additional DES implantation. Thus, for lesions which develop restenosis after LES implantation, the optimal treatment strategy remains unknown. Few results on small sample-size populations have been reported in patients treated with scoring or cutting balloon (SCB) technology for treatment of BMS restenosis as compared to plain balloon angioplasty. Moreover, the efficacy of SCB angioplasty in DES restenosis has not been adequately addressed. Furthermore, the potential additive benefit of SCB angioplasty in patients undergoing PCB therapy remains to be elucidated. The hypothesis behind this concept is that the application of SCB prior to deployment of PCB may increase the bioavailability of paclitaxel within the restenotic tissue, and therefore may increase the efficacy of PCB. There are numerous preclinical studies to support this hypothesis, which show that lesion preparation is an important pre-requisite for the effectiveness of PCB.
Interventions
DEVICEPaclitaxel Eluting Balloon + Scoring Balloon
Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
Standard balloon lesion predilation; paclitaxel-eluting balloon therapy
Sponsors
Biotronik AG
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels. * Written, informed consent by the patient or her/his legally-authorized representative for participation in the study. * In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion criteria
* Age \< 18 years * Cardiogenic shock * Acute ST-elevation myocardial infarction within 48 hours from symptom onset. * 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. * Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) * Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome * Therapy including Lovastatin, Ciclosporin, Terfenadine, Midazolam, or Ondansetron * Pregnancy (present, suspected or planned) or positive pregnancy test. * Previous enrollment in this trial. * Patient's inability to fully comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment percent diameter stenosis | 6-8 months | In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-segment binary angiographic restenosis | 6-8 month | diameter stenosis ≥50% in the in-segment area (including the interventional area as well as 5 mm margins proximal and distal) at follow-up angiography |
| Death or myocardial infarction | 1 and 2 years | Combined incidence of death or myocardial infarction at one and two year |
| In-stent late lumen loss | 6-8 months | The difference between minimal lumen diameter post-procedure and minimal lumen diameter at follow-up angiography |
| Target lesion thrombosis | 1 and 2 years | Incidence of target lesion thrombosis at one and two years |
| OCT tissue characterization | 6-8 months | Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up |
| Target lesion revascularization | 1 and 2 years | Need for target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia at one and two year follow-up |
Countries
Germany
Outcome results
None listed