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Completed

NCT Number: NCT00597142

A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.

The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.

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Key information

Conditions

Atherosclerotic Lesions in the Aortorenal Ostium Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sarasota Memorial Hospital Care System, Sarasota, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for PTRA and stenting.
  • One or more of the following: (1-3)
  • Hypertension
  • Recurrent "flash" pulmonary edema out of proportion to any impairment of left ventricular function
  • Renal Dysfunction
  • Single, de novo, or restenotic (from prior PTRA) atherosclerotic lesion in the ostium of the renal artery
  • Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
  • Renal Artery Stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney

Exclusion criteria

  • Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure
  • Advanced renal disease: serum creatinine > 3.0 mg/dl
  • End stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis
  • Recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.)
  • Documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable)
  • Documented allergy to heparin, acetylsalicylic acid (ASA) or clopidogrel
  • NYHA Class IV
  • Bleeding diathesis
  • Thrombocytopenia (platelets < 100,000/mm3)
  • Renal atrophy (renal length ≤ 8 cm determined by renal ultrasound)
  • Patients requiring immunosuppressive therapy
  • Renal allograft
  • Stenosis location in a vascular graft or in a transplant artery Angiographic Exclusion
  • Total occlusions
  • Thrombus containing lesion
  • Prior treatment of target lesion with stent (in-stent restenosis)
  • More than one (1) lesion in target vessel
  • Non-atherosclerotic stenosis (fibromuscular dysplasia)
  • Excessive vessel tortuosity
  • Lesion involving a side-branch
  • Lesion in accessory renal artery
  • Abdominal aortic aneurysm > 3.5 cm
  • Perforated vessels evidenced by extravasation of contrast media

Treatment and study plan

Express™ Renal Premounted Stent System

Device

This device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a:

  • Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery
  • Lesion length ≤15mm
  • Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
  • RVD 4.0-7.0mm

Primary outcomes

  1. Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.

    Time frame: 9 months

Secondary outcomes

  1. Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.

    Time frame: Post stent deployment

  2. Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.

    Time frame: 9 months

  3. Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.

    Time frame: 9 Months

  4. Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups

    Time frame: 9 months

  5. Change in Renal to Aortic Ratio, Resistive Index, and Peak Systolic Velocity using Ultrasound Core Lab values from pre-procedure to postprocedure and 9-months post-procedure.

    Time frame: 9 Months

  6. Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups

    Time frame: 9 Months

  7. Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure

    Time frame: 9 Months

  8. Technical success as visually assessed by the investigator.

    Time frame: Immediately after stent deployment

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: RENAISSANCE

Important dates

Study start
2004
Primary completion
2005
Study completion
2009
First posted
Jan 17, 2008
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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