NCT00595647

Brief Summary

Prospective multicenter controlled randomized trial to compare the safety and efficacy of drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving DES than in patients receiving BMS regarding both short-term and long-term outcome.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
3 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

6.1 years

First QC Date

January 4, 2008

Last Update Submit

April 19, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR

    12 months

Secondary Outcomes (1)

  • Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding

    30 days and 6, 12, 36, and 60 months

Study Arms (2)

1

ACTIVE COMPARATOR

Percutaneous coronary intervention

Device: Drug eluting stent

2

PLACEBO COMPARATOR

Percutaneous coronary intervention

Device: Bare metal stent

Interventions

Drug eluting stentDEVICE

Implantation of stent

Also known as: TAXUS Liberté
1
Bare metal stentDEVICE

Implantation of stent

Also known as: Liberté
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate)
  • Documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome

You may not qualify if:

  • Previous stent implantation anywhere in the target SVG
  • Concomitant native vessel PCI
  • SVG age \<6 months
  • Arterial grafts
  • Oral anticoagulation
  • Platelet count \<100x109/L or \>700x109/L, white blood cell count \<3000 cells/mm3
  • Any major non-cardiac condition with a life expectancy \<12 months
  • Planned elective surgery in the next 12 months
  • Known allergies against the components tested
  • Enrolled in other study
  • No consent
  • Patients unlikely to comply to the study treatment and the follow-up visits
  • Age \<18 years
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshospitalet

Copenhagen, Denmark

Location

Gentofte Hospital

Hellerup, Denmark

Location

University of Leipzig/Heart Center

Leipzig, Germany

Location

University Hospital Basel

Basel, Switzerland

Location

Triemli Hospital

Zurich, Switzerland

Location

Related Publications (1)

  • Fahrni G, Farah A, Engstrom T, Galatius S, Eberli F, Rickenbacher P, Conen D, Mueller C, Pfister O, Twerenbold R, Coslovsky M, Cattaneo M, Kaiser C, Mangner N, Schuler G, Pfisterer M, Mobius-Winkler S, Jeger RV; BASKET-SAVAGE-Investigators*. Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial. J Am Heart Assoc. 2020 Oct 20;9(20):e017434. doi: 10.1161/JAHA.120.017434. Epub 2020 Oct 9.

    PMID: 33032485DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Matthias Pfisterer, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Raban Jeger, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Sven Möbius-Winkler, MD

    University of Leipzig/Heart Center, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. / MD

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

DK(2)DE(1)CH(2)