Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™ (PEPCAD-DEBonly)

Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.

Study Overview

• Status: Terminated
• Conditions: Coronary De-novo Stenoses
• Intervention / Treatment: Device: SeQuent®Please (Paclitaxel coated balloon); Device: Taxus™Liberté™ (Paclitaxel eluting stent)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22527
    • Medizinisches Versorgungszentrum
  • Brandenburg
    • Postdam, Brandenburg, Germany, 14467
      • Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Clinical evidence of stable or unstable angina or a positive functional study
• Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
• Diameter stenosis > 70% (visual estimate)
• Vessel diameter 2.5 - 3.5 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
• Patient's and treating physician's 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%
• Visible thrombus proximal to the lesion
• Expection that treatment with devices other than PTCA will be required for this lesion.
• Stenosis is within a bypass graft
• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, 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, cause 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).
• Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
• Chronic renal insufficiency with serum creatinine > 2.0 mg%
• 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 which may inter-fere with the interpretation of results of this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequent®Please	Device: SeQuent®Please (Paclitaxel coated balloon); PCI of de-novo lesions
Active Comparator: Taxus™Liberté™	Device: Taxus™Liberté™ (Paclitaxel eluting stent); PCI of de-novo lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss	Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombotic occlusion of the target lesion		30 days, 6, 12, 24, 60 months
Revascularization of the target lesion		30 days, 6, 12, 24, 60 months
Myocardial infarction		30 days, 6, 12, 24, 60 months
Death		30 days, 6, 12, 24, 60 months
Combined clinical endpoint (MACE)	consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death	30 days, 6, 12, 24, 60 months

Collaborators and Investigators

• Sponsor: University Hospital, Saarland
• Investigators: Principal Investigator: Bruno Scheller, Prof. Dr. med, Uniklinikum des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Paclitaxel; de-novo; coronary stenoses; PEPCAD; DEBonly
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: Pac 14