NCT00670436

Brief Summary

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

1.6 years

First QC Date

April 29, 2008

Last Update Submit

June 7, 2014

Conditions

Coronary Artery DiseaseChronic Total OcclusionNative Coronary Artery

Outcome Measures

Primary Outcomes (1)

  • Late loss

    6 months

Secondary Outcomes (6)

  • percent diameter stenosis

    6 months

  • binary angiographic restenosis rate

    6 months

  • late loss index

    6 months

  • Target lumen revascularization

    30 days, 6, 12, 24 months

  • target vessel revascularization

    30 days, 6, 12, 24 months

  • +1 more secondary outcomes

Study Arms (2)

A 1

ACTIVE COMPARATOR

paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery

Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)

A2

ACTIVE COMPARATOR

historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)

Device: paclitaxel eluting Taxus stent (Boston Scientific)

Interventions

paclitaxel eluting PTCA balloon catheter (SeQuent Please)DEVICE

paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery

Also known as: SeQuent Please, paclitaxel eluting balloon
A 1
paclitaxel eluting Taxus stent (Boston Scientific)DEVICE

paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

A2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic total occlusion
  • Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
  • occlusion in native coronary artery
  • indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
  • reference diameter 2.5 mm to 4.0 mm

You may not qualify if:

  • saphenous vein graft
  • bifurcation lesion with need to stent main and side branch
  • left main occlusion
  • de-novo stenosis (no occlusion)
  • restenosis
  • in-stent restenosis
  • contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
  • coronary aneurysm at target lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Wohrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8.

    PMID: 22511572BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jochen Wöhrle, MD; FESC

    University of Ulm, Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jochen Wöhrle

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

DE(2)