Back to resultsTreatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)
Primary Purpose
Coronary Restenosis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
PTCA
paclitaxel coated balloon catheter (device with drug)
Sponsored by
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
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 < 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 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Uncoated Angioplasty
DCB Angioplasty
Arm Description
PTCA of ISR
DCB PTCA of ISR
Outcomes
Primary Outcome Measures
angiographic late lumen loss
angiographic late lumen loss
Secondary Outcome Measures
binary restenosis rate
binary restenosis rate
major adverse cardiac events
major adverse cardiac events
Full Information
NCT ID
NCT00106587
First Posted
March 25, 2005
Last Updated
April 25, 2023
Sponsor
University Hospital, Saarland
1. Study Identification
Unique Protocol Identification Number
NCT00106587
Brief Title
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)
Official Title
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2003 (Actual)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Saarland
4. Oversight
5. Study Description
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.
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=52 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%, < 25 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
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uncoated Angioplasty
Arm Type
Active Comparator
Arm Description
PTCA of ISR
Arm Title
DCB Angioplasty
Arm Type
Experimental
Arm Description
DCB PTCA of ISR
Intervention Type
Device
Intervention Name(s)
PTCA
Intervention Type
Combination Product
Intervention Name(s)
paclitaxel coated balloon catheter (device with drug)
Primary Outcome Measure Information:
Title
angiographic late lumen loss
Description
angiographic late lumen loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
binary restenosis rate
Description
binary restenosis rate
Time Frame
6 months
Title
major adverse cardiac events
Description
major adverse cardiac events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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
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
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Speck, PhD
Organizational Affiliation
Radiologie, Campus Mitte, Charite, Berlin, Germany
Official's Role
Study Director
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
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
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
derived
Learn more about this trial
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)
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