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Trial record 40 of 77 for:    "Heart Disease" | "Cobalt"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462631
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : February 19, 2016
B. Braun Medical SA
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Stenosis Diabetes Mellitus Device: Paclitaxel Eluting Balloon Device: paclitaxel eluting stent Device: bare metal stent Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Late lumen loss at 9 months [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Procedural success [ Time Frame: during procedure ]
  2. Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis [ Time Frame: 3 years ]
  3. 30-day MACE rate [ Time Frame: 30 days ]
  4. Percent in-stent stenosis at 9 months [ Time Frame: 9 months ]
  5. Percent in-segment stenosis at 9 months [ Time Frame: 9 months ]
  6. In-stent late loss index at 9 months [ Time Frame: 9 months ]
  7. Angiographic binary in-stent stenosis rate at 9 months [ Time Frame: 9 months ]
  8. In-segment late loss index at 9 months [ Time Frame: 9 months ]
  9. Angiographic binary in-segment stenosis rate at 9 months [ Time Frame: 9 months ]
  10. Acute and cumulative MACE rate at 9 months [ Time Frame: 9 months ]
  11. Cumulative MACE rate after 2 years [ Time Frame: 2 years ]
  12. Indication for premature follow-up [ Time Frame: up to 9 months ]
  13. Type of recurrence (Mehran-Classification) [ Time Frame: 9 months ]
  14. Target vessel failure [ Time Frame: 9 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462631

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ralf Degenhardt, PhD, Data Manager, Heart Centre Rotenburg Identifier: NCT00462631     History of Changes
Other Study ID Numbers: BBM-VS-55
PEPCAD IV/CRI/06-03/n-c
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Keywords provided by Ralf Degenhardt, PhD, Heart Centre Rotenburg:
coronary artery
Additional relevant MeSH terms:
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Heart Diseases
Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action