Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)

NCT00106587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-04-27

No results posted yet for this study

Summary

The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Conditions

  • Coronary Restenosis

Interventions

DEVICE

PTCA

COMBINATION_PRODUCT

paclitaxel coated balloon catheter (device with drug)

Sponsors & Collaborators

  • University Hospital, Saarland

    lead OTHER

Principal Investigators

  • Bruno Scheller, MD · Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany

  • Ulrich Speck, PhD · Radiologie, Campus Mitte, Charite, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-11-30
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00106587 on ClinicalTrials.gov