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INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent
This study is currently recruiting participants.
Verified by Heart Centre Rotenburg, September 2008
Sponsors and Collaborators: Heart Centre Rotenburg
B. Braun Melsungen AG
Information provided by: Heart Centre Rotenburg
ClinicalTrials.gov Identifier: NCT00747357
  Purpose

The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of de-novo and restenotic lesions in native coronary arteries. The study will be conducted in India.


Condition Intervention Phase
Coronary Heart Diseases
Device: Drug Eluting Balloon SeQuent Please
Phase III

MedlinePlus related topics: Coronary Artery Disease Heart Diseases
Drug Information available for: Paclitaxel Chromium Cobalt
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title: The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent to Treat Coronary Artery Disease in a Real World Scenario

Further study details as provided by Heart Centre Rotenburg:

Primary Outcome Measures:
  • Late lumen loss at 6 months in-segment and in-stent for each treated coronary stenosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 125
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Balloon first
Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
2: Experimental
Stent First
Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon

Detailed Description:

The aim of the study is to evaluate the efficacy and safety of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment in a real world scenario including up to two de-novo or restenotic lesions ( no in-stent restenoses) in two different native coronary arteries (reference diameter: 2.5mm and 4.0mm, length of stenosis 10mm and 25mm) for procedural success and preservation of vessel patency up to 3 years

  Eligibility

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

Inclusion Criteria:

  • 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)
  • Patients must be older then 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.
  • 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 year and 3 year clinical follow-up

Lesion Related (relates to up to 2 stenoses in two different coronary arteries to be treated per protocol)

  • Reference diameters ranging from 2.5 mm to 4.0 mm and length of stenosis from 10 mm to ≤ 25 mm
  • Diameter stenosis pre procedure must be either more then 70 % or more then 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, or scintigraphy
  • Coverage of the target lesion must be intended and possible by a single Paclitaxel-eluting balloon

Exclusion Criteria:

Patient Related

  • 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).
  • Patients with severe valvular heart disease
  • Women who are pregnant or lactating
  • Patients with life expectancy of less than five years or factors making clinical follow-up difficult
  • 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
  • Patients with percutaneous coronary intervention during the six months prior to enrollment into this study

Lesion Related

  • Evidence of extensive thrombosis within target vessel before the intervention
  • Side branch > 2 mm in diameter originating from the lesion
  • Percutaneous coronary intervention of venous graft
  • Target segment is occluded of (i.e., acute or chronic)
  • In-stent restenosis (restenoses in non-stented segments are permitted)
  • Ostial lesion within 2 mm of vessel origin
  • Patients with another coronary stent implanted previously into the target vessel proximal to the target lesion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747357

Contacts
Contact: Upendra Kaul, Dr. +91 9811150518 ukaul@vsnl.com

Locations
India
Upendra Kaul Recruiting
New Delhi, India, 110025
Contact: Upendra Kaul, Dr     +919811150518     ukaul@vsnl.com    
Principal Investigator: Upendra Kaul, Dr.            
Sponsors and Collaborators
Heart Centre Rotenburg
B. Braun Melsungen AG
Investigators
Principal Investigator: Upendra kAUL, Dr. Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India
  More Information

Responsible Party: B. Braun Melsungen AG ( Indranil Mukherjee )
Study ID Numbers: BBM-VS-57INDICOR/CRI/07-02/n-c
Study First Received: September 4, 2008
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00747357  
Health Authority: India: Institutional Review Board

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Chromium
Paclitaxel
Cobalt
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009