Magnetic Navigation for Contrast and Radiation Reduction

NCT01276808 | Unknown

• 1 other identifier: WO nummer R-10.420
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and irradiation for patients undergoing percutaneous coronary intervention. The investigators aim to compare the use of the 2 techniques. Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by a clinical prediction rule). Study design: Prospective randomised controlled, single-blind trial Study population: Healthy human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the placement of the angioplasty wire with magnetic navigation and the other has the angioplasty wire placed by conventional technique. All other interventions will be performed as per routine practice. Main study parameters/endpoints: Primary endpoint The primary endpoint is the amount of contrast used. Secondary endpoints

1. 1.Contrast needed to cross a lesion
2. 2.procedural time
3. 3.radiation exposure
4. 4.Clinical complications at 1 and 12 months
5. 5.procedural success

Conditions

Coronary Artery Disease

Keywords

Magnetic navigation, percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Total procedural contrast fluid use

  1 year

Secondary Outcomes (5)

• Short-term procedural success

  1 year

• Procedure Fluoroscopy

  1 year

• Procedure time

  1 year

• Short term contrast nephropathy

  1 year

• MACCE at 1 month and 12 months

  2 years

Study Arms (2)

Magnetic navigation PCI

EXPERIMENTAL

These patients will be treated with magnetically navigated percutaneous coronary intervention

Procedure: Magnetic navigation PCI

Conventional PCI

ACTIVE COMPARATOR

These patients will be treated with normal standard percutaneous coronary intervention

Procedure: Conventional PCI

Interventions

Magnetic navigation PCI PROCEDURE

Magnetically navigated angioplasty wire technique

Also known as: coronary angioplasty, Percutaneous coronary intervention

Magnetic navigation PCI

Conventional PCI PROCEDURE

Conventional manual angioplasty wire percutaneous coronary intervention

Also known as: coronary angioplasty, Percutaneous coronary intervention

Conventional PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Elective presentation for PCI, This implies that the coronary anatomy is known and can be analysed according to the clinical prediction rule.(13)
• The included patients must have a calculated formula with a result equal or greater than 6.
• Pct=1\*Vb+1\*(Vl=1)+2\*(Vl=2)+2\*Vc+1\*Lbb)+1\*(Ll=1)+2\*(Ll=2)
• Pct - Predicted crossing time (prolonged if integer ≥ 6). Vb - Number of bends before the lesion. Each bend causes deformation of the wire resulting in friction. A greater number of bends leads to increased friction resulting in more difficultly in manipulating the wire.
• Vl - End-to-end length from the ostium to the lesion. The more distal the lesion is from the ostium, then the greater the chance of encountering problematic bends that impair manipulation, and also the longer the time required to physically pass the wire. This is divided into shorter than 50 mm (=0), between 50 and 100 mm (=1) and greater then 100 mm (=2).
• Vc - Vessel calcification. Calcium may increase friction as the vessel becomes more rigid and less deformable and does not conform to the wire. The frictive effect of a specific angle will be accentuated if deformation cannot occur.
• Lbb - Side-branches within 10 mm. Side-branches within 10 mm of the lesion increase difficultly because, on the approach to a lesion finer control is necessary, the fixed wire-tip angle needed for bends now may have more of a predisposition for side-branches.
• Ll - Lesion length. Longer lesions produce more friction on the wire. The detailed analysis of 3D reconstruction by the Paeion system has been described earlier.(12) This rule was tested on a validation group taken from a second cohort of 415 lesions. The c-statistic derived from this group was 0.82 showing good discrimination.
• Patients can be admitted from the lounge, the ward or the CCU
• Diagnostic coronary angiography films suitable for 3D reconstruction Informed consent obtained.

You may not qualify if:

• Active bleeding
• Cardiogenic shock
• Resuscitation / intubation
• Cerebrovascular accident within 30 days
• Major bleeding within 30 days according to the TIMI definitions
• Severe hypertension (\>180/110) after medical treatment
• Relevant trauma or surgery within 6 weeks
• Active peptic ulcer within 3 months
• Hemorrhagic retinopathy
• Thrombocytopenia (\<150)
• Severe renal dysfunction (Creatinine \>140)
• Ongoing or desired use of GpIIb/IIIa blockers
• Participation in another clinical study
• Women who are pregnant or women who are breast-feeding. Inability to follow the patient (e.g. foreign or long-distance patients on holiday)

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091 AC, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mark S Patterson, PhD

  Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Patterson, PhD

CONTACT

020 5993440; dr.markspatterson@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

NL (1)