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Comparison of Coronary Lithoplasty and Rotablation

NCT ID: NCT04047368

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2022-06-28

Brief Summary

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This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.

Detailed Description

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Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.

Conditions

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Coronary Artery Disease Calcified Atheroma

Keywords

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Percutaneous coronary intervention Rotablation Coronary lithoplasty Optical coherence tomography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rotablation

Group Type ACTIVE_COMPARATOR

Rotablation

Intervention Type PROCEDURE

Percutaneous Coronary Intervention using Rotablation

Coronary Lithoplasty

Group Type EXPERIMENTAL

Coronary Lithoplasty

Intervention Type PROCEDURE

Percutaneous Coronary Intervention using Lithoplasty

Interventions

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Rotablation

Percutaneous Coronary Intervention using Rotablation

Intervention Type PROCEDURE

Coronary Lithoplasty

Percutaneous Coronary Intervention using Lithoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age\>18 yrs
* Stable coronary heart disease or acute coronary syndromes
* Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
* Written informed consent was obtained before the procedure
* Severely calcified coronary lesion with indication for rotablation

Exclusion Criteria

* Known renal insufficiency (serum creatinine clearance \<30ml/min/1.73m² or receiving dialysis)
* Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
* Cardiogenic shock
* Lesion length \> 32mm
* Bifurcation lesions requiring 2-Stent-Strategies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Else Kröner-Fresenius Stiftung, Bad Homburg, Germany

UNKNOWN

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Blachutzik, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Giessen

Locations

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University of Giessen

Giessen, , Germany

Site Status

Countries

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Germany

References

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Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.

Reference Type DERIVED
PMID: 37012181 (View on PubMed)

Other Identifiers

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ROTA.shock

Identifier Type: -

Identifier Source: org_study_id