NCT00404144

Brief Summary

The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and \< 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

4.6 years

First QC Date

November 24, 2006

Last Update Submit

March 17, 2015

Conditions

Coronary Stenosis

Keywords

small vesselpaclitaxel coated balloon catheterpepcaddrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss at 6 months

    6 month

Secondary Outcomes (8)

  • Procedural success

    during procedure

  • 30-day MACE rate

    30 days

  • Percent stenosis at 6 months

    6 months

  • Binary restenosis rate at 6 months

    6 months

  • Late loss index at 6 months

    6 months

  • +3 more secondary outcomes

Study Arms (1)

Drug Eluting Balloon

EXPERIMENTAL

treatment of small vessel with drug eluting balloon

Device: Drug Eluting Balloon

Interventions

Drug Eluting BalloonDEVICE

PCI of small vessels single arm study

Drug Eluting Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty or coronary artery bypass grafting)
  • 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 who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
  • Patients must agree to undergo the 6 months angiographic follow-up
  • Patients must agree to undergo the 1 and 3 year clinical follow-up
  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g., balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document
  • Patients with medical indication for follow-up angiography
  • Reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length
  • Diameter stenosis pre procedure must be either \> 70 % or \>50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, or scintigraphy
  • The target lesion must be covered by a single Paclitaxel-eluting balloon

You may not qualify if:

  • Patients with acute (\< 24 h) or recent (≤ 48 hours) myocardial infarction
  • Patients with unstable angina pectoris (Braunwald class 3)
  • Patients with severe congestive heart failure
  • Patients with severe heart failure NYHA IV
  • Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mm Hg requiring inotropic support, IABP and/or fluid challenge).
  • Women who are pregnant or lactating
  • Patients with another coronary stent implanted previously into the target vessel
  • Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
  • 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)
  • Addiction to any drug or to alcohol
  • Patients with any type of surgery during the week preceding the interventional procedure
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kerckhoff-Clinic Bad Nauheim

Bad Nauheim, D-61231, Germany

Location

Unfallkrankenhaus Berlin

Berlin, D-12683, Germany

Location

Medizinische Klinik, Kardiologie, St.-Johannes -Hospital

Dortmund, D-44137, Germany

Location

Städtische Kliniken Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie

Esslingen am Neckar, D-73730, Germany

Location

Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin III

Halle, D-06097, Germany

Location

University of Heidelberg, Clinic for Internal Medicine, Dept. of Cardiology

Heidelberg, D-69120, Germany

Location

University of Saarland, Internal Medicine III

Homburg/Saar, D-66421, Germany

Location

Universitätklinikum Jena, Klinik für Innere Medizin

Jena, D-07740, Germany

Location

Center for Cardiovascular Diseases, Cardiologic Clinic

Rotenburg A.d. Fulda, D-36199, Germany

Location

Related Publications (2)

  • Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.

    PMID: 24058078DERIVED

  • Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.

    PMID: 20052480DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • M. Unverdorben, MD,PhD

    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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Manager

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2010

Study Completion

September 1, 2012

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

DE(9)