NCT01214148

First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions

A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical follow-ups take place at 1 month and yearly up to three (3) years. The objective of this trial is to assess the safety and clinical performance of the ORSIRO drug eluting stent in patients with single de-novo coronary artery lesions.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	ORSIRO - Drug Eluting Coronary Stent	The coronary stent is delivered to the intended implantation location by means of the fast-exchange delivery system and then expanded to its final diameter by dilating the balloon. It remains in the vessel as a permanent implant.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-04-01
• Completion: 2013-07-01
• First posted: 2010-10-04
• Last updated: 2013-08-12

Locations

2 sites across 1 country: Romania