Clinical trial NCT00961181: Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
Official title: Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In-stent Coronary Artery Restenosis
Keywords: paclitaxel
in-stent restenosis
BMS-ISR
DES-ISR
drug eluting balloon
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).

Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patient \>/= 18 years
2. Written patient informed consent available
3. Patients with stable, unstable or documented silent angina pectoris
4. Patient eligible for percutaneous coronary intervention
5. Patient acceptable candidate for coronary artery bypass surgery
6. Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
7. Target reference vessel diameter (visual estimation): 2 - 4 mm
8. Target lesion length (visual estimation): 8 - 28 mm
9. Target lesion stenosis (visual estimation): \>/= 50% - \< 100%

Exclusion Criteria:

1. Left ventricular ejection fraction of \< 30%
2. Visible thrombus in the target vessel visualized by angiography
3. Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required.

   Notes:

   Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I \> 2 fold the upper limit of normal must not be included in the trial.
4. Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
5. Lesion length longer than length of available treatment balloon
6. Impaired renal function (serum creatinine \> 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)
7. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
8. Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
9. Target lesion located in vessel bifurcation
10. Previous and/or planned brachytherapy of target vessel
11. Target lesion located in left main coronary artery
12. Stroke or TIA \< 6 months prior to procedure
13. Patient with signs of a cardiogenic shock
14. Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)
15. Surgeries of any kind within 30 days prior to screening
16. Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
17. Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel
18. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)
19. Patient with a life expectancy of less than one year
20. Patient currently enrolled in other investigational device or drug trial
21. Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy
22. Patient not able or willing to adhere to follow-up visits including follow-up angiography

Primary outcomes:
measure: In-stent Late Lumen Loss
timeFrame: 6 months
Secondary outcomes:
measure: In-segment Late Lumen Loss
timeFrame: 6 months
measure: Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)
timeFrame: 6 months
measure: Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)
timeFrame: 12 months
measure: In-stent Diameter Stenosis (%DS)
timeFrame: 6 months
measure: In-segment Diameter Stenosis (%DS)
timeFrame: 6 months
measure: Binary In-stent Restenosis
timeFrame: 6 months
measure: Binary In-segment Restenosis
timeFrame: 6 months
measure: Technical Success
timeFrame: directly after intervention (after finalized treatment)
measure: Device Success
timeFrame: directly after intervention (after finalized treatment)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Prof. Dr. Christoph Hehrlein
Study officials:
affiliation: University Medical Center, Freiburg i.Br., Germany
name: Christoph Hehrlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hehrlein C, Dietz U, Kubica J, Jorgensen E, Hoffmann E, Naber C, Lesiak M, Schneider H, Wiemer M, Tolg R, Richardt G. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med. 2012 Sep-Oct;13(5):260-4. doi: 10.1016/j.carrev.2012.06.002. Epub 2012 Aug 4.