FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial
Bibliographic record
Abstract
BACKGROUND: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. OBJECTIVE: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. METHODS: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years. RESULTS: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. CONCLUSIONS: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51480.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".