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

NCT00393315 | Completed Phase 2

• 2 other identifiers: BBM-VS-53PEPCAD II/CRI/05/-02/c-c
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

In-Stent Restenosis

Keywords

in stent restenosis; paclitaxel coated balloon catheter; pepcad; drug eluting balloon

Outcome Measures

Primary Outcomes (1)

• Late lumen loss at 6 months

Secondary Outcomes (15)

• Procedural success

• 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

Interventions

paclitaxel coated balloon catheter DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead
• B. Braun Melsungen AG: collaborator

Study Sites (10)

Kerckhoff-Clinic Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Medizinische Klinik, Kardiologie, Charité - Hochschulmedizin Berlin

Berlin, 13353, Germany

Location

Klinikum Darmstadt, Medizinische Klinik I

Darmstadt, 64283, Germany

Location

Medizinische Klinik, Kardiologie, St.-Johannes -Hospital

Dortmund, 44137, Germany

Location

Städtische Kliniken Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie

Esslingen am Neckar, 73730, Germany

Location

University of Saarland, Internal Medicine III

Homburg/Saar, 66421, Germany

Location

I. Med. Abteilung, Krankenhaus Bogenhausen

München, 81925, Germany

Location

University of Regensburg

Regensburg, 93053, Germany

Location

Center for Cardiovascular Diseases, Cardiologic Clinic

Rotenburg A.d. Fulda, 36199, Germany

Location

Related Publications (9)

• 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.

  PMID: 16864669 BACKGROUND

• Custodis F, Scheller B, Laufs U. [Stable coronary artery disease -- case report]. Dtsch Med Wochenschr. 2006 Mar 17;131(11):554-5; quiz 563-4. doi: 10.1055/s-2006-933695. No abstract available. German.

  PMID: 16538559 BACKGROUND

• Speck U, Scheller B, Abramjuk C, Bernhardt U. Drug delivery by angiographic contrast media: inhibition of restenosis. Acad Radiol. 2005 May;12 Suppl 1:S14-7. doi: 10.1016/j.acra.2005.02.017. No abstract available.

  PMID: 16106539 BACKGROUND

• 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: 15302790 BACKGROUND

• 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: 15076010 BACKGROUND

• 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: 14563585 BACKGROUND

• 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: 12909076 BACKGROUND

• Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study. EuroIntervention. 2015 Dec;11(8):926-34. doi: 10.4244/EIJY14M08_12.

  PMID: 25169589 DERIVED

• Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

  PMID: 19487593 DERIVED

Study Officials

• Martin Unverdorben, MD, PhD

  Clinical Research Institute, Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg a.d. Fulda, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: November 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2007
• Last Updated: June 30, 2010

Record last verified: 2010-06

Locations

DE (10)