Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a randomized H215O PET/CT Study

Completed

Conditions: 10011082
coronary arteriosclerosis
Obstructive coronary artery disease

Registration Number: NL-OMON39000

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Patients with documented obstructive CAD by invasive coronary angiography resulting in myocardial ischemia (either documented by invasive (i.e. fractional flow reserve, FFR) or noninvasive imaging techniques (e.g. exercise ECG, myocardial perfusion imaging, or inducibility of wall motion abnormalities during dobutamine stress).
- Presence of a single, de-novo lesion in a native coronary artery (type A or B1), with a reference vessel diameter of at least 3.0 mm and a diameter stenosis of 50% or more and less than 100%, with a thrombolysis in myocardial infarction (TIMI) flow grade of at least 2. Coronary lesion must be amendable for successful treatment with one of the following BRS device dimensions: length 18 or 28 mm, diameter 3.0 or 3.5 mm.
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Exclusion Criteria

- refusal or inability to provide written informed consent
- other than single CAD
- abnormal echocardiographic findings (i.e. wall motion abnormalities, ventricular hypertrophy, valvular disease etc.)
- complex coronary lesion characteristics (e.g. lesions located in the left main coronary artery, lesions involving a side branch more than 2 mm in diameter, and the presence of thrombus or another clinically significant stenosis in the target vessel)
- poor kidney function defined as an eGFR < 30 ml/min
- astma or chronic obstructive pulmonary disease
- other than sinus rhythm
- pregnancy
- bail out stenting after placement of the study device

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MBF measurements: resting MBF, during endothelial dependent vasodilation<br /><br>provoked by cold-pressor-testing (CPT), and during (endothelial dependent and<br /><br>independent) maximal vasodilation by infusion of adenosine intravenously</p><br>

Secondary Outcome Measures