The Promus Element Rewards Study

MedStar Health

Status: Unknown

Conditions: Coronary Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01794065

REWARDS PE

Details and patient eligibility

About

This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, male or female, 18 years or older;
• Patients with de-novo coronary lesions and slated to receive a Promus Element stent;
• Patients who are slated to undergo IVUS after stent deployment during implantation procedure

Exclusion criteria

• Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure;
• Patients with in-stent restenosis;
• Patients who had IVUS imaging attained with manual pullback.

Trial design

500 participants in 5 patient groups

Cypher

Description:

100 patients who have received a Cypher stent during their coronary intervention

Taxus Express

Description:

100 patients who have received a Taxus Express stent during their coronary intervention

Endeavor

Description:

100 patients who have received an Endeavor stent during their coronary intervention

Promus/Xience V

Description:

100 patients who have received a Promus/Xience V stent during their coronary intervention

Promus Element

Description:

100 patients who have received a Taxus Element stent during their coronary intervention