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

NCT00747357 | Completed Phase 3 DMC

• 1 other identifier: BBM-VS-57INDICOR/CRI/07-02/n-c
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Late lumen loss at 6 months in-segment and in-stent for each treated coronary stenosis

  6 months

Study Arms (2)

1

EXPERIMENTAL

Balloon first

Device: Drug Eluting Balloon SeQuent Please

2

EXPERIMENTAL

Stent First

Device: Drug Eluting Balloon SeQuent Please

Interventions

Drug Eluting Balloon SeQuent Please DEVICE

Drug Eluting Balloon is followed by Bare Metal Stent

Also known as: SeQuent® Please DEB

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ralf Degenhardt, PhD: lead
• B. Braun Melsungen AG: collaborator

Study Sites (1)

Upendra Kaul

New Delhi, 110025, India

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Upendra kAUL, Dr.

  Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Data Manager

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

IN (1)