Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients (PEPCAD IV)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg
ClinicalTrials.gov Identifier:
NCT00462631
First received: April 18, 2007
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency.

This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand.

128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center.

Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area.

Late lumen loss at 9 months is the primary endpoint.


Condition Intervention Phase
Coronary Stenosis
Diabetes Mellitus
Device: Paclitaxel Eluting Balloon
Device: paclitaxel eluting stent
Device: bare metal stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paclitaxel-Eluting Balloon Angioplasty and Cobalt-Chromium Stents Versus Conventional Angioplasty and Paclitaxel-Eluting Stents in the Treatment of Native Coronary Artery Stenoses of Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Heart Centre Rotenburg:

Primary Outcome Measures:
  • Late lumen loss at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedural success [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • 30-day MACE rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Percent in-stent stenosis at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Percent in-segment stenosis at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-stent late loss index at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Angiographic binary in-stent stenosis rate at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-segment late loss index at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Angiographic binary in-segment stenosis rate at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Acute and cumulative MACE rate at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Cumulative MACE rate after 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Indication for premature follow-up [ Time Frame: up to 9 months ] [ Designated as safety issue: Yes ]
  • Type of recurrence (Mehran-Classification) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target vessel failure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: May 2007
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
paclitaxel eluting balloon followed by bare metal stent
Device: Paclitaxel Eluting Balloon
Paclitaxel eluting balloon
Device: bare metal stent
bare metal stent
Active Comparator: 2
Paclitaxel eluting stent
Device: paclitaxel eluting stent
paclitaxel eluting stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of diabetes mellitus of at least 3 yrs prior to enrollment. Diabetes mellitus may be treated either orally or s.c.
  • Stable blood glucose level for the 6 months preceding enrollment as reflected by HbA1c concentrations measured exclusively ≤ 8 %
  • 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
  • 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 9 months angiographic follow-up
  • Patients must agree to undergo the 3 year clinical follow-up
  • De-novo native coronary artery stenosis (reference diameter: ≥2.5 mm and ≤ 3.5 mm, length of stenosis: ≥ 10 mm and ≤ 20 mm)
  • Target lesion is ≥ 3 mm distant from a major side branch (> 2.0 mm in diameter) and ≥ 3 mm form a previously deployed stent of any type (including active and passive coatings, bare metal stents)
  • The target lesion must be treated with a single stent only (multiple stenting shifts the patient to the intention-to-treat group)
  • Single or multi-vessel coronary artery disease

Exclusion Criteria:

  • 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 with severe valvular heart disease
  • Women who are pregnant or lactating
  • Patients with another coronary stent implanted previously into the target vessel, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD IV DM PCI
  • 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., malignancy)
  • Addiction to any drug or to alcohol
  • Patients with any type of surgery during the week preceding the interventional procedure.
  • Therapy with anticoagulants
  • Poorly controlled diabetes mellitus as reflected by an HbA1c ≥ 8% during the six months prior to enrollment in PEPCAD IV DM
  • Patient has a history of peptic ulcer or gastric/intestinal bleeding during the past 6 months.
  • Evidence of extensive thrombosis within target vessel before the intervention
  • Side branch > 2 mm in diameter originating from the lesion
  • Stent within the same vessel less than 3 mm distant from target lesion
  • Multi-lesion percutaneous coronary intervention within one vessel (PCI of a total of two lesions one each in a different vessels is permitted)
  • Target lesion located in any type of coronary bypass (i.e., venous graft, arterial bypass) or graft/native artery connection
  • Coronary artery occlusions of any type (e.g., acute or chronic)
  • In-stent restenosis
  • In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462631

Locations
Malaysia
Cardiology Department, Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400
Sponsors and Collaborators
Heart Centre Rotenburg
B. Braun Medical SA
Investigators
Principal Investigator: Rosli M Ali, MD Cardiology Department Institut Jantung Negara National Heart Institute
  More Information

No publications provided by Heart Centre Rotenburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ralf Degenhardt, PhD, Data Manager, Heart Centre Rotenburg
ClinicalTrials.gov Identifier: NCT00462631     History of Changes
Other Study ID Numbers: BBM-VS-55, PEPCAD IV/CRI/06-03/n-c
Study First Received: April 18, 2007
Last Updated: October 1, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Heart Centre Rotenburg:
coronary artery
Diabetes

Additional relevant MeSH terms:
Constriction, Pathologic
Diabetes Mellitus
Coronary Stenosis
Pathological Conditions, Anatomical
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014