Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

NCT00961181 | Completed Results DMC

• 1 other identifier: C0902
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

In-stent Coronary Artery Restenosis

Keywords

paclitaxel; in-stent restenosis; BMS-ISR; DES-ISR; drug eluting balloon

Outcome Measures

Primary Outcomes (1)

• In-stent Late Lumen Loss

  In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon. Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

  6 months

Secondary Outcomes (9)

• In-segment Late Lumen Loss

  6 months

• Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)

  6 months

• Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)

  12 months

• In-stent Diameter Stenosis (%DS)

  6 months

• In-segment Diameter Stenosis (%DS)

  6 months

Study Arms (1)

Paclitaxel Releasing Balloon

EXPERIMENTAL

Percutaneous coronary intervention with paclitaxel releasing balloon

Device: Paclitaxel Releasing Balloon

Interventions

Paclitaxel Releasing Balloon DEVICE

Percutaneous coronary intervention with paclitaxel releasing balloon

Also known as: Pantera Lux

Paclitaxel Releasing Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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% - \< 100%

You may not qualify if:

• Left ventricular ejection fraction of \< 30%
• Visible thrombus in the target vessel visualized by angiography
• 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.
• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (1)

Prof. Dr. Christoph Hehrlein

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (1)

• 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.

  PMID: 22867706 RESULT

Limitations and Caveats

Single arm design. Optimal time point for a quantitative angiographic follow up should be scheduled after 12 months, as recommended by the Academic Research Consortium guidelines for DES.

Results Point of Contact

• Title: Prof. Dr. Christoph Hehrlein
• Organization: University Medical Center, Freiburg i.Br., Germany

christoph.hehrlein@uniklinik-freiburg.de

+49 761 270

Study Officials

• Christoph Hehrlein, MD

  University Medical Center, Freiburg i.Br., Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 18, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: May 6, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-05

Locations

DE (1)