Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries, the DESSOLVE III Study

One of the patient's coronary arteries has a significant narrowing that is
causing decreased blood flow to the heart muscle. To
prevent damage to the heart muscle, this narrowing has to be resolved. This is
commonly done with a percutaneous coronary
intervention (PCI). The procedure is performed by entering the arteries with a
catheter through the groin or arm. By X-ray, the
coronary arteries are made visible. A balloon and then a stent are placed
within the narrowing in the artery to achieve the
desired result; a reopened artery with good blood flow.
Stent placement means that a small metal scaffold (stent) is left behind after
the balloon is removed and the stent becomes a
permanent part of the artery. Stents have been used for many years to treat
narrowing of both coronary arteries. There are
simple metal stents and drug eluting stents (DES) In this trial 2 drug eluting
stents will be used. The procedure itself is a standard procedure for this
condition.

This protocol will provide data to comply with regulatory requirements as well
as gain substantial additional information on patients in a real world
setting. This protocol will compare clinical outcomes of the MISTENT and
XIENCE in a broad patient and lesion population. These data may also be used to
support regulatory approvals in other countries and provide data on various
lesion types that may be treated in order to expand the indications for
MISTENT.

This is a prospective, randomized, 1:1 balanced, controlled, single-blind,
multi-center study comparing clinical outcomes at 12 months between MISTENT and
XIENCE in a *Real world, all comers* patient population (patients with
symptomatic coronary artery disease including patients with chronic stable
angina, silent ischemia, and acute coronary syndromes, who qualify for
percutaneous coronary interventions).


All patients will be (at minimum) contacted at 30 days and 12 months post
procedure to assess clinical status and adverse events. The 30 day and 12 month
will be a clinic visit.All patients will have phone contact at 6 month, 2 and 3
years follow-up to assess clinical status and adverse events. Additionally, 2
phone calls will be performed in the prolongation of the trial; patients are
being called 4 year post procedure and 5 year post procedure.

Enrollment of 1400 patients with 700 MISTENT and 700 XIENCE, Approximately 17
sites in Europe will participate.

The potential risks and undesirable effects resulting from the use of these
stents are the same as for other stents. These are (but are not limit to):
death, stroke, heart attack, renewed narrowing of the coronary artery treated
with the stent or of another coronary artery, need for emergency bypass surgery
or repeat angioplasty.

Undesirable events that may occur due to the procedure, such as artery spasm,
lack of oxygen for the heart, or damage to the coronary artery, blood clots in
the coronary artery or a side vessel, bleeding, for example at the insertion
site for the catheter, and the possible need for a blood transfusion.
Additionally, damage may occur to blood vessels from the insertion site of the
catheter towards the heart, infection and pain at the catheter insertion site,
heart arrhythmias that may be life-threatening, blood pressure changes,
allergic reactions to medicines, contrast medium or stent materials.

Fortunately, serious complications are extremely rare, such as clot formation
in the arteries that can lead to a stroke or cerebral bleed.

In general, a complication is associated with the severity of the heart disease.

The potential risks for pregnancy associated with this treatment are unknown,
and use of adequate contraception during the course of the study is mandatory
for women of childbearing potential.