CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Rotational Atherectomy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02502851
NCT02502851N/ACompleted
CompareCT.gov

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

Segeberger Kliniken GmbH·interventional·Posted Jul 20, 2015·Updated Apr 1, 2020

In Brief

A clinical study evaluating Rotational Atherectomy and Cutting/Scoring Balloon for Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Atherosclerosis Due to Severely Calcified Coronary Lesion
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 20, 2015
Enrollment StartSep 1, 2014
Primary CompletionJul 1, 2018
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.0 years ago

Interventions

Rotational Atherectomydevice

Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent

Cutting/Scoring Balloondevice

Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent