N/A
Completed N=81
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
In-stent Coronary Artery Restenosis
Source: ClinicalTrials.gov NCT00961181 ↗
Enrolled (actual)
81
Serious AEs
14.5%
Results posted
May 2013
Primary outcomePrimary: In-stent Late Lumen Loss — 0.07 mm
Summary
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Lumen Loss |
0.07 | — |
| SECONDARY In-segment Late Lumen Loss |
0.02 | — |
| SECONDARY Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization) |
5 | — |
| SECONDARY Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR) |
9 | — |
| SECONDARY In-stent Diameter Stenosis (%DS) |
25.9 | — |
| SECONDARY In-segment Diameter Stenosis (%DS) |
29.9 | — |
| SECONDARY Binary In-stent Restenosis |
2 | — |
| SECONDARY Binary In-segment Restenosis |
1 | — |
| SECONDARY Technical Success |
81 | — |
| SECONDARY Device Success |
80 | — |
Eligibility Criteria
Inclusion Criteria
- Patient >/= 18 years
- Written patient informed consent available
- Patients with stable, unstable or documented silent angina pectoris
- Patient eligible for percutaneous coronary intervention
- Patient acceptable candidate for coronary artery bypass surgery
- Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
- Target reference vessel diameter (visual estimation): 2 - 4 mm
- Target lesion length (visual estimation): 8 - 28 mm
- Target lesion stenosis (visual estimation): >/= 50% - 2 fold the upper limit of normal must not be included in the trial.
- Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
- Lesion length longer than length of available treatment balloon
- Impaired renal function (serum creatinine > 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)
- Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
- Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
- Target lesion located in vessel bifurcation
- Previous and/or planned brachytherapy of target vessel
- Target lesion located in left main coronary artery
- Stroke or TIA < 6 months prior to procedure
- Patient with signs of a cardiogenic shock
- Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)
- Surgeries of any kind within 30 days prior to screening
- Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
- Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)
- Patient with a life expectancy of less than one year
- Patient currently enrolled in other investigational device or drug trial
- Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy
- Patient not able or willing to adhere to follow-up visits including follow-up angiography
Data sourced from ClinicalTrials.gov (NCT00961181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.