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

Segeberger Kliniken GmbH200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical inclusion criteria * Age above 18 years and consentable * Angiographically proven coronary artery disease * Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve * Written informed consent 2. Angiographic inclusion criteria * De-novo lesion in a native coronary artery * Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation * Luminal diameter reduction of 50-100% by visual estimation * Severe calcification of the target lesion Exclusion Criteria: 1. Clinical exclusion criteria * Myocardial infarction (within 1 week) * Decompensated heart failure * Limited long term prognosis due to other conditions 2. Angiographic exclusion criteria * Target lesion is in a coronary artery bypass graft * Target lesion is an in-stent restenosis * Target vessel thrombus

Locations (1)

Segeberger Kliniken GmbH

Bad Segeberg, Schleswig-Holstein, Germany

Outcomes

Primary Outcomes

Strategy Success

The primary endpoint will be 'Strategy Success' defined as successful stent delivery and expansion with attainment of \< 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without crossover or stent failure

Time frame: Intraprocedural

In-Stent late lumen loss at 9 months

Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography.

Time frame: 9 months

Secondary Outcomes

Target vessel failure (TVF)

Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI; Q- or non-Q-wave) and clinically driven target vessel revascularization (TVR) at 9 months, 1 and 2 years

Time frame: 9 months, 1 year, 2 years

In-segment late lumen loss at 9 months

In-segment late lumen loss (stent length + 5 mm on either side) at 9 months

Time frame: 9 months

In-segment binary restenosis at 9 months

In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months

Time frame: 9 months

Stent thrombosis at 9 months, 1 and 2 years

Time frame: 9 months, 1 and 2 years

Peri-procedural MI

Time frame: within 72 hrs

Data from ClinicalTrials.gov

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