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

Ralf Degenhardt, PhD

Status and phase

Completed

Phase 3

Conditions

Coronary Heart Diseases

Treatments

Device: Drug Eluting Balloon SeQuent Please

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00747357

BBM-VS-57INDICOR/CRI/07-02/n-c

Details and patient eligibility

About

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.

Full 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

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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