Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies

Phase 3 Unknown 204 enrolled University Hospital Tuebingen Acrostak · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.

Timeline

Start: 2005-08
Primary completion: —
Completion: 2007-07

Outcome

Met primary endpoint

paper 0.61+/-0.44 mm in group I versus 0.99+/-0.72 mm in group II (I versus II, P=0.0006) PMID 20031731 ↗

paper 0.44+/-0.48 mm in group III (noninferiority of I versus III, P=0.023). PMID 20031731 ↗

Publications

Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	—	Other