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

February 18, 2016 updated by: Ralf Degenhardt, PhD

The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent to Treat Coronary Artery Disease in a Real World Scenario

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110025
        • Upendra Kaul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Balloon first
Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
Other Names:
  • SeQuent® Please DEB
Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon
Other Names:
  • SeQuent® Please DEB
EXPERIMENTAL: 2
Stent First
Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
Other Names:
  • SeQuent® Please DEB
Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon
Other Names:
  • SeQuent® Please DEB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late lumen loss at 6 months in-segment and in-stent for each treated coronary stenosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ralf Degenhardt, PhD

Collaborators

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Upendra kAUL, Dr., Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (ESTIMATE)

September 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBM-VS-57INDICOR/CRI/07-02/n-c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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