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

June 29, 2010 updated by: University Hospital, Saarland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Clinic Bad Nauheim
      • Berlin, Germany, 12683
        • Unfallkrankenhaus Berlin
      • Berlin, Germany, 13353
        • Medizinische Klinik, Kardiologie, Charité - Hochschulmedizin Berlin
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt, Medizinische Klinik I
      • Dortmund, Germany, 44137
        • Medizinische Klinik, Kardiologie, St.-Johannes -Hospital
      • Esslingen, Germany, 73730
        • Städtische Kliniken Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie
      • Homburg/Saar, Germany, 66421
        • University of Saarland, Internal Medicine III
      • München, Germany, 81925
        • I. Med. Abteilung, Krankenhaus Bogenhausen
      • Regensburg, Germany, 93053
        • University of Regensburg
      • Rotenburg a.d. Fulda, Germany, 36199
        • Center for Cardiovascular Diseases, Cardiologic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Late lumen loss at 6 months

Secondary Outcome Measures

Outcome Measure
Procedural success
Indication for premature follow-up
Target vessel failure
Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis
30-day MACE rate
Percent in-stent stenosis at 6 months
Percent in-segment stenosis at 6 months
In-stent late loss index at 6 months
Angiographic binary in-stent stenosis rate at 6 months
In-segment late loss index at 6 months
Angiographic binary in-segment stenosis rate at 6 months
Acute and cumulative MACE rate at 6 months
Cumulative MACE rate after one year
Cumulative MACE rate after three years
Type of recurrence (Mehran-Classification)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

B. Braun Melsungen AG

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 26, 2006

First Submitted That Met QC Criteria

October 26, 2006

First Posted (Estimate)

October 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBM-VS-53
  • PEPCAD II/CRI/05/-02/c-c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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