PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis (PERVIDEO I)
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|ClinicalTrials.gov Identifier: NCT00916279|
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : December 21, 2015
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|In-Stent Restenosis||Device: Lutonix Paclitaxel-Coated Balloon||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2011|
|Experimental: Lutonix Catheter||
Device: Lutonix Paclitaxel-Coated Balloon
Other Name: Drug Coated Balloon
- Percent Diameter Stenosis (%DS) in the Analysis Segment [ Time Frame: 6 months ]
- Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months [ Time Frame: 6 Months ]Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
- Late Lumen Loss [ Time Frame: 6 months ]Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).
- MACE Rate [ Time Frame: 30 Days ]Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
- Binary Restenosis [ Time Frame: 6 Months ]Subjects with percent diameter stenosis >50% in the analysis segment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916279
|Onze Lieve Vrouw Ziekenhuis|
|Aalst, Belgium, 9300|
|Bad Nauheim, Germany, 61231|
|Westdeutsches Herzzentrum Essen|
|Alte Clinic Center for Cardiology|
|Hamburg, Germany, 22527|
|Herzzentrum Leipzig GmbH|
|Academic Medical Center|
|Sint Antonius Ziehenhuis|
|Principal Investigator:||Laura Mauri, MD||Brigham & Women's Hospital, Boston, MA|