NCT02502851

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Segeberger Kliniken GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.

Conditions

• Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Interventions

Type	Name	Description
DEVICE	Rotational Atherectomy	Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent
DEVICE	Cutting/Scoring Balloon	Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-07-01
• Completion: 2019-10-01
• First posted: 2015-07-20
• Last updated: 2020-04-01

Locations

1 site across 1 country: Germany