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Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

Primary Purpose

Coronary Restenosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

paclitaxel coated balloon catheter (device with drug)

About this trial

This is an interventional treatment trial for Coronary Restenosis focused on measuring in stent restenosis, paclitaxel coated balloon catheter, paccocath, drug eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 < 30 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

Exclusion Criteria:

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

Sites / Locations

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Kardiologie, Campus Mitte, Charite
Kardiologie, Campus Virchow-Klinikum, Charite
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
I. Medizinische Klinik, Universitaetsklinikum

Outcomes

Primary Outcome Measures

angiographic late lumen loss

Secondary Outcome Measures

binary restenosis rate; major adverse cardiac events

Full Information

NCT ID

NCT00409981

First Posted

December 11, 2006

Last Updated

December 11, 2006

Sponsor

University Hospital, Saarland

1. Study Identification

Unique Protocol Identification Number

NCT00409981

Brief Title

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

Official Title

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Saarland

4. Oversight

5. Study Description

Brief Summary

The PACCOCATH ISR II 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.

Detailed Description

Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR. Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=56 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 30 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Restenosis

Keywords

in stent restenosis, paclitaxel coated balloon catheter, paccocath, drug eluting balloon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

56 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

paclitaxel coated balloon catheter (device with drug)

Primary Outcome Measure Information:

Title

angiographic late lumen loss

Secondary Outcome Measure Information:

Title

binary restenosis rate; major adverse cardiac events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 < 30 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Scheller, MD

Organizational Affiliation

University of Saarland, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

City

Homburg / Saar

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

Kardiologie, Campus Mitte, Charite

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Kardiologie, Campus Virchow-Klinikum, Charite

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

I. Medizinische Klinik, Universitaetsklinikum

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15302790

Citation

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.

Results Reference

background

PubMed Identifier

15076010

Citation

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.

Results Reference

background

PubMed Identifier

14563585

Citation

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.

Results Reference

background

PubMed Identifier

12909076

Citation

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.

Results Reference

background

PubMed Identifier

17101615

Citation

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.

Results Reference

background

PubMed Identifier

16864669

Citation

Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.

Results Reference

background

PubMed Identifier

22440499

Citation

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.

Results Reference

derived

PubMed Identifier

18536865

Citation

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.

Results Reference

derived

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Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

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