Cost-Effectiveness Study in the Reduction of Coronary Res... | NCT00627900

Studies
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents

NCT00627900

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

958Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

bare metal stent
Cypher-Stent (Implantation of a sirolimus-eluting stent)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Sep 2008Estimated

Completion Date

Not provided

First Submitted Date

Feb 24, 2008

First Submission Date that Met QC Criteria

Feb 24, 2008

First Posted Date

Mar 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Name	Class
Techniker Krankenkasse	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.

The study "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.

In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.

In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

958Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS	Other	Implantation of a bare metal stent	Device: bare metal stent
SES	Other	Implantation of a sirolimus-eluting stent	Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bare metal stent	Device	implantation of a bare metal stent	BMS
Cypher-Stent (Implantation of a sirolimus-eluting stent)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents		3,6,12,18,24, 36 months following stent implantation

Secondary Outcomes

Measure	Description	Time Frame
MACE (re-PCI, myocardial infarction, CABG, death)		3,6,12,24,36 months after stent implantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for implantation of a coronary stent
de novo lesions < or = 30 mm in patients with diabetes
de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes

Exclusion Criteria:

acute MI
lesion length >30 mm
in-stent restenosis
distal lesion in RVD < 2.25 mm
lesion in left main or bypass vessel
contraindication to Clopidogrel

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan N Willich, MD, MPH, MBA	Charite University, Berlin, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie		Berlin		10098	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18060612	Result	Bruggenjurgen B, McBride D, Bode C, Hamm CW, Kuck KH, Willich SN. Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study. Herz. 2007 Dec;32(8):650-5. doi: 10.1007/s00059-007-3048-2.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases