Current partner codePEPTIDESDE
NCT00419055·Not applicable·OBSERVATIONAL

Outpatient Percutaneous Coronary Intervention

Status

Terminated

Phase

Not applicable

Enrollment

100

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

Full detailed description

A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Interventions

Treatment arms and agents.

PROCEDURE

Early discharge after percutaneous coronary intervenntion

Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.

Timeline

From registration to results.

  1. First posted

    Jan 8, 2007

  2. Study start

    Aug 2004

  3. Primary completion

    Not reported

  4. Study completion

    Aug 2006

  5. Results posted

    Not reported

  6. Registry updated

    Apr 2, 2012

Outcomes

What the study measures.

Primary outcomes

The primary endpoints are patient satisfaction and safety.

Time frame · 30 days

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention Exclusion Criteria: * Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction \<30%, those with history of IV Dye allergy, creatinine level\>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin\<11.0 g/dl, platelets \<100,000 tho/ul)

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.