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

NCT02502851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-04-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Segeberger Kliniken GmbH

    lead OTHER

Principal Investigators

  • Mohamed Abdel-Wahab, MD · Segeberger Kliniken GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-07-31
Completion
2019-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502851 on ClinicalTrials.gov