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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00009868
Date of registration:	13/01/2016
Prospective Registration:	Yes
Primary sponsor:	Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie
Public title:	Procedural and Clinical Outcome after Low Speed Coronary Rotational Atherectomy
Scientific title:	Procedural and Clinical Outcome after Low Speed Coronary Rotational Atherectomy - LS_CoRA
Date of first enrolment:	20/01/2016
Target sample size:	180
Recruitment status:	Pending
URL:	http://drks.de/search/en/trial/DRKS00009868
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
Phase:

Countries of recruitment
Austria

Contacts

Name:	Oliver Friedrich
Address:	Heinrich-Collin-Str. 30 1140 Wien Austria
Telephone:	+ 43 1 910 21-85211
Email:	o.friedrich@karl-landsteiner.at
Affiliation:	Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie

Name:	Oliver Friedrich
Address:	Heinrich-Collin-Str. 30 1140 Wien Austria
Telephone:	+ 43 1 910 21-85211
Email:	o.friedrich@karl-landsteiner.at
Affiliation:	Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie

Key inclusion & exclusion criteria

Inclusion criteria: Treatment with Slow-Speed Rotablatory Atherectomy
Exclusion criteria: no adequate German language skills to answer patient-reported questionnaires

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

I20-I25

Ischaemic heart diseases

I20-I25

Intervention(s)

Group 1: Procedural and clinical outcome in CAD patients after slow-speed rotablatory atherectomy

Primary Outcome(s)

Procedural outcome
Angiographic success (Quantitative Coronary Angiography, TIMI-flow and myocardial blush prior and after intervention), procedural complications (dissection, perforation, slow flow/no flow, early stent thrombosis, myocardial infarction, cardiac and noncardiac death)

Secondary Outcome(s)

Clinical outcome up to 48 months:
Adverse Events (repeated target and non-target vessel revascularisation – Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting), myocardial infarction; cardiac/non-cardiac death)
Patient reported questionnaires for Health Related Quality of Life and Illness Perception (HeartQoL and BIPQ) at baseline, 6 months, 12 months and at the end of the follow-up period (24-48 months after index event).

Secondary ID(s)

Source(s) of Monetary Support

Boston Scientific Group - ISR program

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 21/12/2015
Contact:

Ethikkommission der Stadt Wien Magistratsabteilung 15 - Gesundheitsdienst [EK der Stadt Wien Magistratsabteilung 15 - Gesundheitsdienst]

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00009868#studyResults

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