Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

NCT ID: NCT00961181

Last Updated: 2013-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-05-31

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.

Conditions

In-stent Coronary Artery Restenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel Releasing Balloon

Percutaneous coronary intervention with paclitaxel releasing balloon

Group Type: EXPERIMENTAL

Paclitaxel Releasing Balloon

Intervention Type: DEVICE

Percutaneous coronary intervention with paclitaxel releasing balloon

Interventions

Paclitaxel Releasing Balloon

Percutaneous coronary intervention with paclitaxel releasing balloon

Intervention Type: DEVICE

Other Intervention Names

Pantera Lux

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Hehrlein, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, Freiburg i.Br., Germany

Locations

Prof. Dr. Christoph Hehrlein

Freiburg im Breisgau, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 22867706 (View on PubMed)

Other Identifiers

C0902

Identifier Type: -

Identifier Source: org_study_id