NCT04047368

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

July 22, 2019

Last Update Submit

November 30, 2023

Conditions

Coronary Artery DiseaseCalcified Atheroma

Keywords

Percutaneous coronary interventionRotablationCoronary lithoplastyOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Minimal Stent Area (End of the Procedure)

    0 days

Secondary Outcomes (7)

  • Minimal/Mean/Maximal Stent Diameter

    0 days

  • Minimal/Mean/Maximal Lumen area

    0 days

  • Minimal/Mean/Maximal Lumen diameter

    0 days

  • Mean/Maximal Stent area

    0 days

  • Incidence of target lesion failure

    0 months; 1 month; 6 months

  • +2 more secondary outcomes

Study Arms (2)

Rotablation

ACTIVE COMPARATOR
Procedure: Rotablation

Coronary Lithoplasty

EXPERIMENTAL
Procedure: Coronary Lithoplasty

Interventions

RotablationPROCEDURE

Percutaneous Coronary Intervention using Rotablation

Rotablation
Coronary LithoplastyPROCEDURE

Percutaneous Coronary Intervention using Lithoplasty

Coronary Lithoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Giessen

Giessen, 35392, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37012181DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AtherectomyAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative Techniques

Study Officials

  • Florian Blachutzik, Dr.

    University of Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

August 6, 2019

Study Start

June 28, 2019

Primary Completion

June 28, 2021

Study Completion

June 28, 2022

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

DE(1)