VQI DELTA Paclitaxel Device Safety Analysis - Phase I Study

2019-10-07 08:56:57 | BioPortfolio


The VQI-DELTA Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel coated balloons and stents in the treatment of peripheral artery disease (PAD) through analysis of the VQI Peripheral Vascular Intervention (PVI) registry module using the DELTA system.


The VQI-DELTA Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module using the DELTA system.

The objective of the VQI - DELTA Paclitaxel Phase I Study is to evaluate the relative safety of Paclitaxel used as an antiproliferative agent in the treatment of symptomatic PAD. We will analyze Paclitaxel Drug Coated Balloons (DCB) and Paclitaxel Drug Eluting Stents (DES), both together and as unique exposures using propensity score matched survival analysis. If a mortality signal is detected we will then analyze factors associated with mortality. Phase I is the retrospective component of the planned study, evaluating the 2-year survival of patients treated with a paclitaxel containing/eluting device to matched patients treated with non-paclitaxel devices for symptomatic PAD.

All proposed analyses will be performed using DELTA v3.x, which has the capability to prospectively monitor clinical data repositories for safety signals, and is designed to support risk-adjusted prospective safety surveillance analyses of complex clinical datasets.

Three principle analyses are planned:

1. Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact and Philips Spectranetics Stellarex DCB's) as compared with propensity matched patients treated with plain balloons.

2. Paclitaxel delivering DES (including the Cook Zilver PTX and Boston Scientific Eluvia DES) as compared with propensity matched cases using bare metal stents (BMS).

3. Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).

Study Design


Peripheral Vascular Disease




Lahey Clinic, Inc.
United States


Active, not recruiting


Lahey Clinic

Results (where available)

View Results


Published on BioPortfolio: 2019-10-07T08:56:57-0400

Clinical Trials [3254 Associated Clinical Trials listed on BioPortfolio]

Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery dis...

Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.

Local Paclitaxel Delivery to Prevent Restenosis in Peripheral Arterial Disease

The purpose of this study is to determine if the addition of a catheter-based local delivery of paclitaxel into the peripheral arterial vessels in patients with peripheral arterial disease...

Diamondback in Peripheral Vascular Disease

This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if th...

PubMed Articles [19988 Associated PubMed Articles listed on BioPortfolio]

Does nab-paclitaxel have a higher incidence of peripheral neuropathy than solvent-based paclitaxel? Evidence from a systematic review and meta-analysis.

Paclitaxel-induced peripheral neuropathy is a common reason for dose reduction or early cessation of therapy. Nab-paclitaxel was developed to provide additional clinical benefits and overcome the safe...

Taxane-Induced Peripheral Neuropathy: Objective and Subjective Comparison Between Paclitaxel and Docetaxel in Patients With Breast Cancer.

Taxane-induced peripheral neuropathy (TIPN) is caused by the neurotoxicity of paclitaxel and docetaxel, but the differences between paclitaxel- and docetaxel-induced peripheral neuropathy are understu...

Peripheral Vascular Anomalies - Essentials in Periinterventional Imaging.

 Peripheral vascular anomalies represent a rare disease with an underlying congenital mesenchymal and angiogenetic disorder. Vascular anomalies are subdivided into vascular tumors and vascular malfo...

Gene dysregulation in peripheral blood of moyamoya disease and comparison with other vascular disorders.

Moyamoya disease (MMD) is a chronic occlusive cerebrovascular disease with unknown etiology, sharing many similar clinical symptoms with other vascular disorders. This study aimed to investigate gene ...

Relationship between lower limb vascular characteristics, peripheral arterial disease and gait in rheumatoid arthritis.

Rheumatoid arthritis (RA) is associated with higher risk of atherosclerotic vascular disease, including peripheral arterial disease (PAD). The aim of this study was to measure lower limb vascular char...

Medical and Biotech [MESH] Definitions

An ergot derivative that has been used as a cerebral vasodilator and in peripheral vascular disease. It has been suggested to ameliorate cognitive deficits in cerebrovascular disease.

Flunarizine is a selective calcium entry blocker with calmodulin binding properties and histamine H1 blocking activity. It is effective in the prophylaxis of migraine, occlusive peripheral vascular disease, vertigo of central and peripheral origin, and as an adjuvant in the therapy of epilepsy.

A beta-adrenergic agonist that causes direct relaxation of uterine and vascular smooth muscle. Its vasodilating actions are greater on the arteries supplying skeletal muscle than on those supplying skin. It is used in the treatment of peripheral vascular disease and in premature labor.

A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

More From BioPortfolio on "VQI DELTA Paclitaxel Device Safety Analysis - Phase I Study"

Quick Search

Relevant Topics

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Vascular relates to blood vessels (Oxford Medical Dictionary) and can be used to describe the supply of blood, a disease affecting the blood vessels or molecules associated with these structures. For example, <!--LGfEGNT2Lhm-->atherosclerosis ...

Searches Linking to this Trial