SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents

This is an investigator-initiated protocol examining the effectiveness of intracoronary
brachytherapy using the Novoste beta-emitting catheter for recurrent stenosis after
treatment with multiple drug-eluting stents. While intracoronary brachytherapy has been used
for this purpose by clinicians for some time, data supporting this clinical decision-making
is lacking.

Currently, when cardiologists find restenosis after implanting a drug-eluting stent, they
often place a stent that elutes a different drug within that stent. If a patient presents
with restenosis in the segment that has already been treated with both sirolimus and
paclitaxel-eluting stents, further options are limited. Intracoronary brachytherapy is often
used in this scenario, but the efficacy of this approach has not been well studied. The
investigators recently reviewed the clinical outcomes of five patients who underwent
intracoronary radiation after drug-eluting stents. They discovered only one episode of
target vessel revascularization and no episodes of stent thrombosis. While this sample is
small, investigators believe that a prospective study will provide important information
regarding this approach.

Inclusion Criteria:

1. Age 18 years or older.

2. Eligible for percutaneous coronary intervention.

3. Target lesion with recurrent restenosis (>50% by visual estimate) previously treated
with any 2 or more combination of DES stents.

4. Signs or symptoms of ischemia attributable to the target lesion, or stenosis > 50% by
visual estimation of the lesion during angiography.

5. Target lesion is located within a native coronary artery or bypass graft.

6. Be reliable, cooperative and willing to comply with all protocol-specified procedures
and follow-up.

7. Able to understand and sign informed consent.

Exclusion Criteria:

1. Confirmed pregnancy at the time of index PCI.

2. Has known allergies to aspirin, and to both clopidogrel (Plavix ®) and ticlopidine
(Ticlid ®).

3. Has known allergies or contraindication to heparin and Bivalirudin (Angiomax ®).

4. Has a significant medical condition which in the investigator's opinion may interfere
with the patient's optimal participation in the study.

5. Any serious disease condition with life expectancy of less than 1 year.

6. Unsuccessful coronary revascularization procedure (residual stenosis > 30%).

7. Angiographic evidence of thrombus.

8. No Previous intracoronary radiation to the target artery.