PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

Segeberger Kliniken GmbH100 enrolled

Overview

A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

Rotational atherectomy in combination with cutting balloonPROCEDURE

Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Clinical inclusion criteria 1. Age above 18 years and consentable 2. Angiographically proven coronary artery disease 3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve 4. Written informed consent Angiographic inclusion criteria 1. De-novo lesion in a native coronary artery 2. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation 3. Luminal diameter reduction of 50-100% by visual estimation 4. Severe calcification of the target lesion (for definition see appendix) Exclusion Criteria: Clinical exclusion criteria 1. Myocardial infarction (within 1 week) 2. Decompensated heart failure 3. Limited long term prognosis due to other conditions Angiographic exclusion criteria 1. Target lesion is in a coronary artery bypass graft 2. Target lesion is an in-stent restenosis 3. Target vessel thrombus

Locations (1)

Herzzentrum Segeberger Kliniken GmbH

Bad Segeberg, Germany

Outcomes

Primary Outcomes

Primary endpoint: Numerical in-stent acute lumen gain in mm

The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.

Time frame: At the end of the index procedure

Co-primary OCT endpoint: Ratio of stent expansion index (SEI)

The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure

Time frame: At the end of the index procedure

Secondary Outcomes

Numerical in-stent late lumen loss at 9 month follow-up angiography in mm

In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint.

Time frame: 9 months follow-up

Rate of angiographic success in percent

'Angiographic 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.

Time frame: Peri-procedural

Rate of strategy success in percent

'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 stent failure.

Time frame: Peri-procedural

Rate of target vessel failure in percent

Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years.

Data from ClinicalTrials.gov

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