NCT00409981

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (planned)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Detailed description

Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR. Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=56 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, \< 30 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.

Conditions

• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	paclitaxel coated balloon catheter (device with drug)

Timeline

• Start date: 2004-07-01
• Completion: 2006-06-01
• First posted: 2006-12-12
• Last updated: 2006-12-12

Locations

5 sites across 1 country: Germany