Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis (PEPPER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT00961181
First received: August 13, 2009
Last updated: May 2, 2013
Last verified: May 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: In-stent Coronary Artery Restenosis
Intervention: Device: Paclitaxel Releasing Balloon

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From 14 August 2009 to 26 April 2010 a total of 81 patients at 9 heart centres in Europe were enrolled. Last follow-up was completed 09 May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No group assignment.

Reporting Groups
  Description
Paclitaxel Releasing Balloon Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.

Participant Flow:   Overall Study
    Paclitaxel Releasing Balloon  
STARTED     81  
COMPLETED     76  
NOT COMPLETED     5  
Death                 2  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paclitaxel Releasing Balloon Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.

Baseline Measures
    Paclitaxel Releasing Balloon  
Number of Participants  
[units: participants]
  81  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     51  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 9.4  
Gender  
[units: participants]
 
Female     18  
Male     63  
Region of Enrollment  
[units: participants]
 
Germany     67  
Poland     9  
Denmark     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   In-stent Late Lumen Loss   [ Time Frame: 6 months ]

2.  Secondary:   In-segment Late Lumen Loss   [ Time Frame: 6 months ]

3.  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)   [ Time Frame: 6 months ]

4.  Secondary:   Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)   [ Time Frame: 12 months ]

5.  Secondary:   In-stent Diameter Stenosis (%DS)   [ Time Frame: 6 months ]

6.  Secondary:   In-segment Diameter Stenosis (%DS)   [ Time Frame: 6 months ]

7.  Secondary:   Binary In-stent Restenosis   [ Time Frame: 6 months ]

8.  Secondary:   Binary In-segment Restenosis   [ Time Frame: 6 months ]

9.  Secondary:   Technical Success   [ Time Frame: directly after intervention (after finalized treatment) ]

10.  Secondary:   Device Success   [ Time Frame: directly after intervention (after finalized treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Dr. Christoph Hehrlein
Organization: University Medical Center, Freiburg i.Br., Germany
phone: +49 761 270 ext 6095
e-mail: christoph.hehrlein@uniklinik-freiburg.de


Publications of Results:

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT00961181     History of Changes
Other Study ID Numbers: C0902
Study First Received: August 13, 2009
Results First Received: March 19, 2013
Last Updated: May 2, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products