NCT01690572

Drug Eluting Balloon for Prevention of Constrictive Remodeling

Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Prof. Dr. med. Christoph Hehrlein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.

Conditions

• Coronary Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Paclitaxel coated balloon catheter	Dilatation of the target lesion
DEVICE	uncoated balloon catheter "sprinter legend"	Dilatation of the target lesion

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-12-01
• Completion: 2017-04-01
• First posted: 2012-09-21
• Last updated: 2017-04-28

Locations

1 site across 1 country: Germany