Contrast Media Reduction and Removal in Patients With CKD (PRESERV)

The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following
injection during percutaneous coronary interventions.

Inclusion Criteria:

- The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI)
procedure of the left coronary artery.

- The subject has documented chronic kidney disease (CKD).

- The subject is willing and able to provide appropriate informed consent.

- The subject is willing and able to comply with the requirements of the study
protocol, including the predefined follow-up evaluations.

Exclusion Criteria:

- The subject has unstable renal function (acute renal failure).

- The subject has received contrast media within 7 days of the procedure.

- The subject will receive iodinated contrast media in any location other than the Left
Coronary Artery during the procedure or within a period of 30 days after the
procedure.

- Hemoglobin <9.5 g/dL

- Requires hemodialysis

- The subject has had acute myocardial infarction (heart attack) within last 24 hours.

- The subject is known to be or suspected to be pregnant.

- The subject is currently participating in another investigational device or drug
study that has not reached its primary endpoint.