MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study

NCT01531725 | Completed Results DMC

• 1 other identifier: C0601
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries.

Conditions

Coronary Artery Disease

Keywords

Stents

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.

  at 180 days post procedure

Secondary Outcomes (1)

• Major Adverse Cardiac Events (MACE)

  at 180 days post procedure

Study Arms (1)

BMS implantation

EXPERIMENTAL

Patients meeting the inclusion criteria and none of the exclusion criteria are treated by implanting the study device (the ProKinetic bare metal stent). Since it is a single arm study design, no patients are enrolled to a control arm.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

Percutaneous coronary intervention

Also known as: PRO-Kinetic stent system

BMS implantation

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years old.
• Eligible for percutaneous coronary intervention (PCI).
• Documented stable (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4) or unstable (Braunwald type I, II, III and A, B or C) angina pectoris, or documented silent ischemia.
• Left ventricular ejection fraction (LVEF) \> 30% documented within the last 6 weeks.
• Acceptable candidate for coronary artery bypass graft surgery (CABG).
• Patient understands the study requirements and the treatment procedures and provides written Informed Consent on a form that has been approved the by local Institutional Review Board before any specific test of the study or procedure is performed.
• Willing to comply with all the specified follow-up evaluations.
• Single target vessels to be treated.
• Single target lesion to be treated.
• Target lesion must be completely coverable by one study stent.
• Total target lesion length \<20 mm based on a visual estimate.
• RVD of ≥ 2.0 mm to ≤ 5.0 mm based on a visual estimate.
• Target lesion diameter stenosis ≥ 50% and \< 100% based on a visual estimate.
• Target lesion has not undergone prior revascularization up to now.
• Target vessel has not undergone prior revascularization within the preceding 6 months.

You may not qualify if:

• Planned treatment with any other PCI device in target vessel except the pre-dilatation balloon.
• MI within 72 hours prior to the index procedure and/or creatine kinase (CK) \> 2 times the local laboratory upper limits of normal, measured on the day of the index procedure, associated with elevated MB.
• The patient is in cardiogenic shock.
• Cerebrovascular Accident (CVA) within the past 6 months.
• Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/L).
• Contraindication to ASA or to clopidogrel.
• Known Thrombocytopenia (platelet count 100, 000/mm3).
• Active gastrointestinal (GI) bleeding within the past three months.
• Known allergy to stainless steel or cobalt chromium.
• Any prior true anaphylactic reaction to contrast agents.
• Patient is currently taking colchicine.
• Life expectancy of less than 24 months due to other medical conditions.
• Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• Left main coronary artery disease (stenosis \> 50%), whether protected or unprotected.

Sponsors & Collaborators

• Biotronik AG: lead

Related Publications (1)

• Vermeersch P, Appelman Y, Horstkotte D, Richardt G, Boland J, Lalmand J, Coussement P, Castadot M, Janssens L, Agostoni P, Buysschaert I, Suttorp MJ. Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study. Cardiovasc Revasc Med. 2012 Nov-Dec;13(6):316-20. doi: 10.1016/j.carrev.2012.09.006.

  PMID: 23164477 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

Limitations: * missing comparators * permission to conduct follow up visits by telephone * limited number of 197 patients allows an insight of the safety and efficacy of the device.

Results Point of Contact

• Title: Paul Vermeersch, MD, PhD
• Organization: ZNA Middelheim Department Interventional Cardiology, Antwerpen, Belgium

paul.vermeersch@zna.be

+32 3 280 3211

Study Officials

• Paul Vermeersch, MD, PhD

  ZNA Middelheim, Department Interventional Cardiology

  PRINCIPAL INVESTIGATOR

• Maarten J. Suttorp, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 13, 2012
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 25, 2013
• Results First Posted: March 19, 2013

Record last verified: 2013-03