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P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses

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ClinicalTrials.gov Identifier: NCT00393315
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : June 30, 2010
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
University Hospital, Saarland

Brief Summary:
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameters between 2.5 mm and 3.5 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus™ stent.

Condition or disease Intervention/treatment Phase
In-Stent Restenosis Device: paclitaxel coated balloon catheter Phase 2

Detailed Description:

Background information:

Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decades.The initial recurrence rate of bare stents in the range of 20 30 % in low risk stenoses has been further reduced by devices with passive coatings such as silicon carbide, heparin, phosphorylcholine, and carbon. The significant decline of in-stent restenoses (= ISR) to the order of 12 % was achieved by active coatings like the cell-cycle inhibitor sirolimus and to about 13.7 % by the cytotoxic paclitaxel. Taken into account the more than one million annual stent procedures performed worldwide even low recurrence rates will leave some hundred thousand repeat procedures annually. In the treatment of in-stent restenoses, however, approaches such as stand alone angioplasty with conventional balloons, the repeat use of bare stents, cutting balloon angioplasty, rotablation, and atherectomy have revealed unsatisfactory and often conflicting results. For brachytherapy the late loss was reported in the range from 0.22 +/- 0.84 mm to 0.73 +/- 0.79mm. Due to its disadvantages such as delayed endothelialization with ensuing late thrombosis cumulating in a 12-months cardiac event rate of up to 30% rising to 50% after five years, its decrease of benefit over time, and the cumbersome logistics at the sites and in the labs, brachytherapy is not considered as a valid approach of the future. Recently, the deployment of drug eluting stents into a restenotic device was associated with restenosis rates in the range from 4% to 30% suggesting some advantage over the aforementioned approaches. The wide range of the results and some late cardiac events still leave room for alternative methods such as the Paclitaxel-eluting PTCA balloon catheter.

Study Rationale The principle of the Paclitaxel-eluting PTCA balloon catheter is based on the antiproliferative mode of action of the compound, the latter being homogenously distributed along the entire length of the balloon and, hence, the vessel segment to be treated. This advantage is in particular relevant in comparison to drug eluting stents as are the lack of chronic mechanical alterations of the artery, the ease of access to the lesion, the obviation of adding another layer of metal to the lesion, and the presumably lower cost of the procedure. Data on the use of the Paclitaxel-eluting PTCA balloon catheter on the treatment of in-stent restenoses, however, are scant. In the animal model and according to unpublished results in humans, the proliferation induced by a Paclitaxel-eluting balloon catheter was significantly less compared to an uncoated balloon and to the Sirolimus-eluting Cypher™ stent.Therefore, it is prudent to compare the direct arterial application of Paclitaxel by means of the Paclitaxel-eluting PTCA balloon catheter versus the Paclitaxel-eluting Taxus™-stent as percutaneous transluminal treatment options of in-stent restenosis in human coronary arteries in a prospective randomized pilot study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses: A Comparison to the Paclitaxel-Eluting Taxus™ Stent. A Pilot Study
Study Start Date : November 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel




Primary Outcome Measures :
  1. Late lumen loss at 6 months

Secondary Outcome Measures :
  1. Procedural success
  2. Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis
  3. 30-day MACE rate
  4. Percent in-stent stenosis at 6 months
  5. Percent in-segment stenosis at 6 months
  6. In-stent late loss index at 6 months
  7. Angiographic binary in-stent stenosis rate at 6 months
  8. In-segment late loss index at 6 months
  9. Angiographic binary in-segment stenosis rate at 6 months
  10. Acute and cumulative MACE rate at 6 months
  11. Cumulative MACE rate after one year
  12. Cumulative MACE rate after three years
  13. Indication for premature follow-up
  14. Type of recurrence (Mehran-Classification)
  15. Target vessel failure


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patient Related

  • Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
  • Patients eligible for coronary revascularization by means of PCI
  • Age at least 18 years of age
  • Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up
  • Patients must agree to undergo the 6 months angiographic follow-up and the 1 and 3 year clinical follow-up Inclusion Criteria: Lesion Related
  • In-stent restenosis or Mehran type III stenoses reaching ≤ 2 mm into the adjacent native vessel of a metal stent (including passive coatings, exclusive of active coatings), i.e., no recurrence in the native vessel adjacent to the stent, after stent deployment in a native coronary artery (reference vessel between 2.5 and 3.5 mm, lesion length ≤ 22 mm as angiographically documented)
  • Diameter stenosis pre procedure must be either at least 70 % or 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
  • In the stent group, the target lesion must be treated with a single stent only (multiple stenting shifts the patient to the intention-to-treat group) Exclusion Criteria: Patient Related
  • Patients with acute (< 24 h) or recent (48 hours) myocardial infarction, unstable angina pectoris (Braunwald class 3)
  • Clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
  • Patients with another coronary stent implanted previously into the target vessel
  • Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
  • Patients who had a cerebral stroke < 6 months prior to the procedure
  • Patient participates in other clinical trials involving any investigational device or drug
  • Untreated hyperthyroidism
  • Patient has presence or history of severe renal failure (GFR<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
  • Post transplantation of any organ or immune suppressive medication
  • Other disease to jeopardize follow-up (e.g., malignoma)
  • Patients with any type of surgery during the week preceding the interventional procedure.
  • Therapy with anticogulants Exclusion Criteria: Lesion Related
  • Evidence of extensive thrombosis within target vessel before the intervention
  • Side branch > 2 mm in diameter originating from the stent
  • Bifurcate lesion
  • Left main coronary artery stenosis
  • Multilesion percutaneous coronary intervention within the same artery
  • Percutaneous coronary intervention of venous graft
  • Coronary artery occlusions of any type
  • In-stent restenosis of a drug eluting stent (DES)
  • In-segment stenosis of the native vessel within the 5 mm adjacent to the stent
  • Lesion within 1 mm of vessel origin
  • Exclusion Criteria Related to Concomitant Medication
  • Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393315


Locations
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Germany
Kerckhoff-Clinic Bad Nauheim
Bad Nauheim, Germany, 61231
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Medizinische Klinik, Kardiologie, Charité - Hochschulmedizin Berlin
Berlin, Germany, 13353
Klinikum Darmstadt, Medizinische Klinik I
Darmstadt, Germany, 64283
Medizinische Klinik, Kardiologie, St.-Johannes -Hospital
Dortmund, Germany, 44137
Städtische Kliniken Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen, Germany, 73730
University of Saarland, Internal Medicine III
Homburg/Saar, Germany, 66421
I. Med. Abteilung, Krankenhaus Bogenhausen
München, Germany, 81925
University of Regensburg
Regensburg, Germany, 93053
Center for Cardiovascular Diseases, Cardiologic Clinic
Rotenburg a.d. Fulda, Germany, 36199
Sponsors and Collaborators
University Hospital, Saarland
B. Braun Melsungen AG
Investigators
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Principal Investigator: Martin Unverdorben, MD, PhD Clinical Research Institute, Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg a.d. Fulda, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bruno Scheller, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00393315    
Other Study ID Numbers: BBM-VS-53
PEPCAD II/CRI/05/-02/c-c
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010
Keywords provided by University Hospital, Saarland:
in stent restenosis
paclitaxel coated balloon catheter
pepcad
drug eluting balloon
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action