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INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Heart Centre Rotenburg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Heart Centre Rotenburg
ClinicalTrials.gov Identifier:
NCT00747357
First received: September 4, 2008
Last updated: October 1, 2012
Last verified: September 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Balloon first
Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
Other Name: SeQuent® Please DEB
Experimental: 2
Stent First
Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon
Other Name: SeQuent® Please DEB

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
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: NCT00747357

Locations
India
Upendra Kaul
New Delhi, India, 110025
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

No publications provided

Responsible Party: Indranil Mukherjee, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00747357     History of Changes
Other Study ID Numbers: BBM-VS-57INDICOR/CRI/07-02/n-c
Study First Received: September 4, 2008
Last Updated: October 1, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014