CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 947 enrolled
Drug / intervention
Atacand/HCT, Caduet +1 moredrug
Likely dose
Renal artery angioplasty and stenting with GENESIS™ Embolic Protection Stent and/or Angioguard Device; medical therapy with Atacand/HCT and Caduet or optimal medical regimen for hypertensionAI-extracted
Key inclusion· 4
  • ✓Documented hypertension on two or more anti-hypertensive medications
  • ✓OR Stage 3+ chronic kidney disease (GFR <60 mL/min/1.73m²) by MDRD formula
  • ✓Severe renal artery stenosis ≥60% by angiogram, OR systolic velocity >300 cm/sec by duplex, OR ≥80% by MRA, OR ≥70% MRA with spin dephasing plus criteria, OR ≥80% by CTA, OR ≥70% CTA plus two secondary criteria
  • ✓Age >18 years
Key exclusion· 17
  • ✕Fibromuscular dysplasia or non-atherosclerotic renal artery stenosis
  • ✕Pregnancy or unknown pregnancy status in female of childbearing potential
  • ✕Stroke within 6 months with residual neurologic deficit
  • ✕Major surgery, trauma, revascularization, unstable angina, or MI within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00081731Phase 3Completed
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Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

Baim Institute for Clinical Research·interventional·Posted Apr 21, 2004·Updated Oct 5, 2015

In Brief

A Phase 3 clinical trial evaluating Atacand/HCT, Caduet and GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting) for Atherosclerosis and 3 related conditions. Completed, enrolled 947 participants across 1 site.

Detailed Summary

This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Cardiovascular Diseases, Hypertension, Renovascular, Renal Artery Obstruction
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2004
Enrollment StartApr 1, 2004
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 22.2 years ago

Interventions

Atacand/HCT, Caduetdrug

Atacand/HCT and caduet or optimal medical therapy for hypertension

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)procedure

Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device