Renal Stenting With Distal Atheroembolic Protection

NCT00868972 | Unknown Phase 2

• 1 other identifier: MOMPF-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function, refractory hypertension and flushing edema, responsible for mortality and morbidity, especially in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no unanimous consent on which patients could benefice of the endovascular procedure due to the high rate of renal adverse events especially linked to atheroembolic disease. Recently, renal revascularization using a device which consents distal embolic protection of the kidney demonstrated to be a "safe" auxiliary procedure in a few non randomized studies. Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after the procedure suggesting that these devices could prevent atheroembolism in a substantial proportion of patients. On the other hand, only a randomized controlled study can prove that renal stent with distal embolic protection is superior to renal stent alone in preserving kidney function. Therefore, the present study aims to compare the effects of renal artery stent placement with or without distal embolic protection on renal function in ARAS patients. Method: Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive medications and/or renal failure (estimated GFR \<60 mL/min/1.73 m2 are randomly assigned to stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX; Cordis Endovascular, USA). Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 3 months. The primary outcome of this study is a statistical significant difference in kidney function measured as Cr clearance and cystatin C level in the 2 groups at three months. The trial will include 150 patients.

Conditions

Renal Artery Obstruction; Renovascular Hypertension

Keywords

Renal Artery Obstruction; renovascular hypertension; stent; Kidney Failure; embolic protection

Outcome Measures

Primary Outcomes (1)

• Differences in renal function loss (measured as Cr clearance and/or cystatin C) after 1 and 3 months of follow-up

  3 months

Secondary Outcomes (3)

• Acute complications, especially atheroembolism

  3 months

• Evaluations of the covariates associated with a better outcome in the atheroembolic device group

  3 months

• Blood pressure control (number of medication needed to keep BP<140/90 )

  3 months

Study Arms (2)

Embolic protection

ACTIVE COMPARATOR

Percutaneous renal stenting using a distal embolic protection device (filter wire ex; Cordis Endovascular, USA).

Procedure: Percutaneous renal stenting intervention; Device: Distal embolic protection

No embolic protection

SHAM COMPARATOR

Percutaneous renal stenting intervention without embolic protection

Procedure: Percutaneous renal stenting intervention

Interventions

Percutaneous renal stenting intervention PROCEDURE

Percutaneous renal stenting intervention

Embolic protection; No embolic protection

Distal embolic protection DEVICE

Distal embolic protection device (filter wire ex; Cordis Endovascular, USA).

Embolic protection

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Ostial atherosclerotic renal artery stenosis ≥70% on intra-arterial angiography
• Well documented history of hypertension (\>140/90 mmHg) non responsive to the use of 2 or more antihypertensive medications and/or
• Estimated glomerular filtration rate \<60 ml/min/1.73m2 according to the MDRD formula, on two occasions within one month

You may not qualify if:

• Declined informed consent
• Renal longitudinal diameter \< 8 cm
• Any anatomical reasons that make impossible the PTRA and or the positioning of the distal embolic protection device
• Estimated glomerular filtration rate \<30 ml/min/1.73m2 according to the MDRD formula or on dialysis
• Allergy to the contrast medium used during angiography
• Other conditions associated with (within 6 months) poor prognosis

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera di Verona, Policlinico G.B. Rossi

Verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction; Hypertension, Renovascular; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension, Renal; Hypertension

Study Officials

• Giancarlo Mansueto, MD, professor

  Univerista di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Mansueto, MD, professor

CONTACT

00390458124301; giancarlo.mansueto@univr.it

Oliviero Olivieri, MD, professor

CONTACT

00390454627; oliviero.olivieri@univr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 25, 2010

Record last verified: 2010-01

Locations

IT (1)