NCT00106587

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_1

Geographic Reach
1 country

5 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

December 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

March 25, 2005

Last Update Submit

April 25, 2023

Conditions

Coronary Restenosis

Keywords

in stent restenosispaclitaxel coated balloon catheterpaccocathdrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • angiographic late lumen loss

    angiographic late lumen loss

    6 months

Secondary Outcomes (2)

  • binary restenosis rate

    6 months

  • major adverse cardiac events

    12 months

Study Arms (2)

Uncoated Angioplasty

ACTIVE COMPARATOR

PTCA of ISR

Device: PTCA

DCB Angioplasty

EXPERIMENTAL

DCB PTCA of ISR

Combination Product: paclitaxel coated balloon catheter (device with drug)

Interventions

PTCADEVICE
Uncoated Angioplasty
paclitaxel coated balloon catheter (device with drug)COMBINATION_PRODUCT
DCB Angioplasty

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Clinical evidence of stable or unstable angina or a positive functional study
  • Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no 'staged' procedures involving non-target lesions)
  • Diameter stenosis \> 70% (visual estimate)
  • Stented segment length \< 25 mm
  • Vessel diameter =\> 2.5 mm
  • Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
  • Signed patient informed consent form
  • Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

You may not qualify if:

  • Left ventricular ejection fraction of \< 30%
  • Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion.
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated.
  • Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
  • Severe chronic renal insufficiency.
  • Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment.
  • Participating in another device or drug study within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg / Saar, Saarland, 66421, Germany

Location

Kardiologie, Campus Mitte, Charite

Berlin, 10117, Germany

Location

Kardiologie, Campus Virchow-Klinikum, Charite

Berlin, 13353, Germany

Location

Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

Freiburg im Breisgau, 79106, Germany

Location

I. Medizinische Klinik, Universitaetsklinikum

Mannheim, 68167, Germany

Location

Related Publications (7)

  • Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

    PMID: 15302790BACKGROUND

  • Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.

    PMID: 15076010BACKGROUND

  • Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.

    PMID: 14563585BACKGROUND

  • Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.

    PMID: 12909076BACKGROUND

  • Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Bohm M, Cremers B. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012 Mar;5(3):323-30. doi: 10.1016/j.jcin.2012.01.008.

    PMID: 22440499DERIVED

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.

    PMID: 18536865DERIVED

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

    PMID: 17101615DERIVED

MeSH Terms

Conditions

Coronary Restenosis

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Bruno Scheller, MD

    Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany

    PRINCIPAL INVESTIGATOR

  • Ulrich Speck, PhD

    Radiologie, Campus Mitte, Charite, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2005

First Posted

March 28, 2005

Study Start

December 1, 2003

Primary Completion

November 1, 2006

Study Completion

March 1, 2012

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

DE(5)